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    Clinical Trial Results:
    A Prospective, Controlled, Randomized, Multi-Center, Exploratory Pilot Study Evaluating the Safety and Potential Trends in Efficacy of Adhexil™

    Summary
    EudraCT number
    		 2007-001326-26
    Trial protocol
    		 DE   GB   ES  
    Global end of trial date
    29 Aug 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Jan 2023
    First version publication date
    01 Jan 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AA-GYN-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00544310
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    OMRIX Biopharmaceuticals Ltd
    Sponsor organisation address
    MDA Blood Bank, Sheba Hospital, Ramat Gan POB 888, Kiryat Ono, Israel, 55000
    Public contact
    Patricia Schleckser, Ethicon Inc, pschleck@its.jnj.com
    Scientific contact
    Richard Kocharian, MD, PhD, Ethicon Inc, rkochar1@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    25 Feb 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Jul 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Aug 2008
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The objective of the study is to evaluate the safety and initial efficacy of the anti-adhesion kit (AA) AdhexilTM for the prevention and/or reduction of post-operative adhesions in patients who are undergoing a surgical procedure involving the ovaries.
    Protection of trial subjects
    Prior to study participation, the procedures and any known or likely risks were explained to the subject by the investigator or other medically qualified co-investigator. An informed consent form was provided containing all the required information. Any questions were answered and the subject was then given sufficient time to consider their participation in the study before signing the consent form. The investigator (or designee) explained to subjects that they were completely free to refuse to enter the study, or to withdraw from it at any time, without any consequences for their further care and without the need to justify their decision. Subjects were made aware that all information would be treated confidentially, and they would be identified by a study code.
    Background therapy
    		 In both the US and EU, several products are marketed for reduction of post-operative adhesions but all have limitations. An ideal adhesion barrier should be non reactive, but protect tissue at risk during the critical wound healing period before being absorbed and cleared, it should remain adherent to the target tissue even in the presence of bleeding and it should be easy to apply during laparoscopic procedures performed on adhesiogenic organs such as ovaries and adnexa. The potential of a variety of materials to reduce the occurrence and severity of adhesion formation has been investigated. This has included agents that affect adhesion formation at various levels, such as fibrinolytic agents, anti inflammatory, antibiotics and mechanical barriers (films, gels and liquids absorbable and non-absorbable). Many of the products developed have been difficult to use in open surgery, and particularly in laparoscopic settings. Adhexil™ anti-adhesion kit consists of the components required to form a protective fibrin polymer together with an application device. The components that form the fibrin polymer, Biological Active Component (BAC) and Thrombin, are human blood derivatives.
    Evidence for comparator
    		 There was no active comparator used in this study. All subjects had their 1st ovary treated with Adhexil and compared to the 2nd ovary which did not receive any treatment.
    Actual start date of recruitment
    23 Oct 2007
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 1 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 7
    Country: Number of subjects enrolled
    Germany: 10
    Worldwide total number of subjects
    17
    EEA total number of subjects
    17
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    17
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 First Subject Enrolled: 23-Oct-07; Last Subject Enrolled: 16-Jul-08, Completed: 29-Aug-08. Each subject enrolled had one ovary treated with Adhexil and other ovary untreated. Thus 17 enrolled subjects resulted in 34 evaluable (17 treated & 17 untreated) ovaries. One subject withdrew after completing index procedure resulting in 32 evaluable ovaries

    Pre-assignment
    Screening details
    		 Prospective subjects were screened within 21 days prior to surgery. Prior to any study related procedures, subjects were fully informed of all aspects of the study and asked to sign a consent form.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind [1]
    Roles blinded
    		 Subject, Assessor
    Blinding implementation details
    Due to the nature of the investigational product in this study, it was not possible for the surgeon to be blinded to treatment. The subject was blinded to treatment received. To avoid any bias in the assessment of incidence, extent and severity of adhesions, both 1st Look Laparoscopy (1LL) and 2nd Look Laparoscopy (2LL) surgeries were recorded on DVD and evaluated by a blinded independent surgeon. The proficiency of Adhexil application was also evaluated by a blinded reviewer.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Treated Ovary (1st Look Laparoscopy)
    Arm description
    		 Undergoing elective laparoscopic surgery due to known or suspected bilateral ovarian disease were enrolled and underwent the index study surgical procedure, referred to as the 1st Look Laparoscopy (1LL).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Adhexil™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implantation matrix
    Routes of administration
    Implantation
    Dosage and administration details
    The amount of Adhexil™ required depended upon the area and location of the site to be treated. Adhexil™ was to be applied so that it extended 1-2 cm beyond the margins of the raw surface. The remaining volume of the kit was then to be applied to the entire assigned ovary and the raw surfaces of adjacent structures at the surgeon’s discretion. It was intended that in most cases, the maximum of 10 mL of Adhexil™ would be applied. Note: Adhexil treatment was applied to 1 of the 2 ovaries of each subject following a randomised assignment.

    Arm title
    		 Untreated Ovary (1st Look Laparoscopy)
    Arm description
    		 Undergoing elective laparoscopic surgery due to known or suspected bilateral ovarian disease enrolled and underwent the index study surgical procedure, referred to as the 1st Look Laparoscopy (1LL).
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Treated Ovary (2nd Look Laparoscopy)
    Arm description
    		 Subjects were to undergo a second look laparoscopy (2LL), 6 (+/- 4) weeks following first laparoscopy if considered beneficial because of the probability of formation of new adhesions.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Adhexil™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implantation matrix
    Routes of administration
    Implantation
    Dosage and administration details
    The amount of Adhexil™ required depended upon the area and location of the site to be treated. Adhexil™ was to be applied so that it extended 1-2 cm beyond the margins of the raw surface. The remaining volume of the kit was then to be applied to the entire assigned ovary and the raw surfaces of adjacent structures at the surgeon’s discretion. It was intended that in most cases, the maximum of 10 mL of Adhexil™ would be applied. Note: Adhexil treatment was applied to 1 of the 2 ovaries of each subject following a randomised assignment.

    Arm title
    		 Untreated Ovary (2nd Look Laparoscopy)
    Arm description
    		 Subjects were to undergo a second look laparoscopy (2LL), 6 (+/- 4) weeks following first laparoscopy if considered beneficial because of the probability of formation of new adhesions.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Notes
    [1] - The roles blinded appear to be inconsistent with a double blind trial.
    Justification: Due to the nature of the investigational product in this study, it was not possible for the surgeon to be blinded to treatment. The subject was blinded to treatment received. To avoid any bias in the assessment of incidence, extent and severity of adhesions, both 1st Look Laparoscopy (1LL) and 2nd Look Laparoscopy (2LL) surgeries were recorded on DVD and evaluated by a blinded independent surgeon. The proficiency of Adhexil application was also evaluated by a blinded reviewer.
    Number of subjects in period 1
    		Treated Ovary (1st Look Laparoscopy) Untreated Ovary (1st Look Laparoscopy) Treated Ovary (2nd Look Laparoscopy) Untreated Ovary (2nd Look Laparoscopy)
    Started
    17
    17
    16
    16
    Completed
    17
    17
    16
    16

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 17 17
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 17 17
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 29.2 (22 to 40) -
    Gender categorical
    Units: Subjects
        Female
    		 17 17
    Diagnosis of Ovarian Disease
    The subjects’ diagnoses of ovarian disease are summarised.
    Units: Subjects
        Endometriosis
    		 8 8
        Teratoma / bilateral teratoma
    		 3 3
        Endometriosis and teratoma
    		 1 1
        Endometriosis and ovarian cyst
    		 3 3
        Endometrial cyst
    		 1 1
        Adhesion and ovarian cyst
    		 1 1
    Race
    Units: Subjects
        Caucasian
    		 17 17
    Ethnicity
    Units: Subjects
        Hispanic/Latino
    		 9 9
        Northern European
    		 8 8
    Subject analysis sets

    Subject analysis set title
    1st Look Laparoscopy
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Seventeen (17) subjects were enrolled and underwent the index study surgical procedure, referred to as the 1st Look Laparoscopy (ILL). Each subject had 1 ovary treated with Adhexil™ and 1 ovary left untreated. In this subject analysis set there are a total of 34 [(17 (treated) +17 - (untreated)] evaluable ovaries.

    Subject analysis set title
    2nd Look Laparoscopy
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    A total of 16/17 subjects completed 2nd Look Laparoscopy, 6 (+/- 4) weeks following first laparoscopy if considered beneficial because of the probability of formation of new adhesions.. Each subject had 1 ovary treated with Adhexil™ and 1 ovary left untreated. In this subject analysis set there are a total of 32 [16 (treated) +16 (untreated)] evaluable ovaries. Note: 1 subject withdrew consent after completing the index procedure.

    Subject analysis sets values
    		 1st Look Laparoscopy 2nd Look Laparoscopy
    Number of subjects
    17
    16
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    17
    16
        From 65-84 years
    0
    0
        85 years and over
    0
    0
    Age continuous
    Units: years
        median (full range (min-max))
    29.2 (22 to 40)
    Gender categorical
    Units: Subjects
        Female
    17
    16
    Diagnosis of Ovarian Disease
    The subjects’ diagnoses of ovarian disease are summarised.
    Units: Subjects
        Endometriosis
    8
    7
        Teratoma / bilateral teratoma
    3
    3
        Endometriosis and teratoma
    1
    1
        Endometriosis and ovarian cyst
    3
    3
        Endometrial cyst
    1
    1
        Adhesion and ovarian cyst
    1
    1
    Race
    Units: Subjects
        Caucasian
    17
    16
    Ethnicity
    Units: Subjects
        Hispanic/Latino
    9
    8
        Northern European
    8
    8

    End points

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    End points reporting groups
    Reporting group title
    Treated Ovary (1st Look Laparoscopy)
    Reporting group description
    		 Undergoing elective laparoscopic surgery due to known or suspected bilateral ovarian disease were enrolled and underwent the index study surgical procedure, referred to as the 1st Look Laparoscopy (1LL).

    Reporting group title
    Untreated Ovary (1st Look Laparoscopy)
    Reporting group description
    		 Undergoing elective laparoscopic surgery due to known or suspected bilateral ovarian disease enrolled and underwent the index study surgical procedure, referred to as the 1st Look Laparoscopy (1LL).

    Reporting group title
    Treated Ovary (2nd Look Laparoscopy)
    Reporting group description
    		 Subjects were to undergo a second look laparoscopy (2LL), 6 (+/- 4) weeks following first laparoscopy if considered beneficial because of the probability of formation of new adhesions.

    Reporting group title
    Untreated Ovary (2nd Look Laparoscopy)
    Reporting group description
    		 Subjects were to undergo a second look laparoscopy (2LL), 6 (+/- 4) weeks following first laparoscopy if considered beneficial because of the probability of formation of new adhesions.

    Subject analysis set title
    1st Look Laparoscopy
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Seventeen (17) subjects were enrolled and underwent the index study surgical procedure, referred to as the 1st Look Laparoscopy (ILL). Each subject had 1 ovary treated with Adhexil™ and 1 ovary left untreated. In this subject analysis set there are a total of 34 [(17 (treated) +17 - (untreated)] evaluable ovaries.

    Subject analysis set title
    2nd Look Laparoscopy
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    A total of 16/17 subjects completed 2nd Look Laparoscopy, 6 (+/- 4) weeks following first laparoscopy if considered beneficial because of the probability of formation of new adhesions.. Each subject had 1 ovary treated with Adhexil™ and 1 ovary left untreated. In this subject analysis set there are a total of 32 [16 (treated) +16 (untreated)] evaluable ovaries. Note: 1 subject withdrew consent after completing the index procedure.

    Primary: Incidence of ovaries with adhesions at completion of 1st Look Laparoscopy and 2nd Look Laparoscopy

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    End point title
    		 Incidence of ovaries with adhesions at completion of 1st Look Laparoscopy and 2nd Look Laparoscopy
    End point description
    End point type
    Primary
    End point timeframe
    Adhesion Assessment and Recording of Laparoscopic Examination was performed after completion of 1st laparoscopic (index) procedure and again after completion of 2nd laparoscopic procedure, 6 (+/- 4) weeks following the index procedure.
    End point values
    		 Treated Ovary (1st Look Laparoscopy) Untreated Ovary (1st Look Laparoscopy) Treated Ovary (2nd Look Laparoscopy) Untreated Ovary (2nd Look Laparoscopy)
    Number of subjects analysed
    17
    17
    16 [1]
    16 [2]
    Units: Number of Adhesions
    number (not applicable)
        Absence of Adhesion
    6
    5
    8
    5
        Presence of Adhesion
    11
    12
    8
    11
    Notes
    [1] - 1 subject was withdrawn from the study, at the subject's request.
    [2] - 1 subject was withdrawn from the study, at the subject's request.
    Statistical analysis title
    		 Primary Endpoint
    Statistical analysis description
    The incidence of ovarian adhesions at 2LL was summarized by treatment and compared using McNemar’s Test to compare the incidence of ovaries with adhesions in Intention to Treat population. The total number of evaluable ovaries (treated and untreated) (shown as "subjects" in the table below) is 34 in 1st Look Laparoscopy and 32 in 2nd Look Laparoscopy (total of 66 observations).
    Comparison groups
    Untreated Ovary (1st Look Laparoscopy) v Treated Ovary (1st Look Laparoscopy) v Treated Ovary (2nd Look Laparoscopy) v Untreated Ovary (2nd Look Laparoscopy)
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 = 0.1797
    Method
    		 Mcnemar
    Confidence interval
    Notes
    [3] - This study was not powered to detect statistical significance. Note: The total number of ovaries (subjects) in this end point analysis (#66) corresponds to the total number of evaluable ovaries (treated and untreated) at 1st and 2nd Look Laparoscopy procedure

    Secondary: Extent of Ovarian Adhesions at 1st Look Laparoscopy and 2nd Look Laparoscopy

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    End point title
    		 Extent of Ovarian Adhesions at 1st Look Laparoscopy and 2nd Look Laparoscopy
    End point description
    End point type
    Secondary
    End point timeframe
    Adhesion Assessment and Recording of Laparoscopic Examination was performed after completion of 1st laparoscopic (index) procedure and again after completion of 2nd laparoscopic procedure, 6 (+/- 4) weeks following the index procedure.
    End point values
    		 Treated Ovary (1st Look Laparoscopy) Untreated Ovary (1st Look Laparoscopy) Treated Ovary (2nd Look Laparoscopy) Untreated Ovary (2nd Look Laparoscopy) 1st Look Laparoscopy 2nd Look Laparoscopy
    Number of subjects analysed
    17
    17
    16 [4]
    16 [5]
    34
    32 [6]
    Units: Subjects
        Overall Observations
    17
    17
    16
    16
    34
    32
        No adhesion
    6
    5
    8
    5
    11
    13
        <1/3 of surface with adhesions
    4
    4
    4
    3
    8
    7
        1/3 to 2/3 of surface with adhesions
    2
    6
    0
    3
    8
    3
        >2/3 of surface with adhesions
    5
    2
    4
    5
    7
    9
    Notes
    [4] - 1 subject was withdrawn from the study, at the subject's request.
    [5] - 1 subject was withdrawn from the study, at the subject's request.
    [6] - 1 subject was withdrawn from the study, at the subject's request.
    No statistical analyses for this end point

    Secondary: Severity of Ovarian Adhesions at 1st Look Laparoscopy and 2nd Look Laparoscopy

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    End point title
    		 Severity of Ovarian Adhesions at 1st Look Laparoscopy and 2nd Look Laparoscopy
    End point description
    End point type
    Secondary
    End point timeframe
    Adhesion Assessment and Recording of Laparoscopic Examination was performed after completion of 1st laparoscopic (index) procedure and again after completion of 2nd laparoscopic procedure, 6 (+/- 4) weeks following the index procedure.
    End point values
    		 Treated Ovary (1st Look Laparoscopy) Untreated Ovary (1st Look Laparoscopy) Treated Ovary (2nd Look Laparoscopy) Untreated Ovary (2nd Look Laparoscopy) 1st Look Laparoscopy 2nd Look Laparoscopy
    Number of subjects analysed
    17
    17
    16 [7]
    16 [8]
    34
    32 [9]
    Units: subjects
        Overall Observations
    17
    17
    16
    16
    34
    32
        No adhesion
    6
    5
    8
    5
    11
    13
        Filmy, avascular
    1
    0
    2
    1
    1
    3
        Dense and/or vascular
    1
    3
    1
    3
    4
    4
        Cohesive
    9
    9
    5
    7
    18
    12
    Notes
    [7] - 1 subject was withdrawn from the study, at the subject's request.
    [8] - 1 subject was withdrawn from the study, at the subject's request.
    [9] - 1 subject was withdrawn from the study, at the subject's request.
    No statistical analyses for this end point

    Secondary: The American Fertility Society Scores for Adhesions of Ovaries and Tubes at 1st Look Laparoscopy and 2nd Look Laparoscopy

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    End point title
    		 The American Fertility Society Scores for Adhesions of Ovaries and Tubes at 1st Look Laparoscopy and 2nd Look Laparoscopy
    End point description
    End point type
    Secondary
    End point timeframe
    Adhesion Assessment and Recording of Laparoscopic Examination was performed after completion of 1st laparoscopic (index) procedure and again after completion of 2nd laparoscopic procedure, 6 (+/- 4) weeks following the index procedure.
    End point values
    		 Treated Ovary (1st Look Laparoscopy) Untreated Ovary (1st Look Laparoscopy) Treated Ovary (2nd Look Laparoscopy) Untreated Ovary (2nd Look Laparoscopy) 1st Look Laparoscopy 2nd Look Laparoscopy
    Number of subjects analysed
    17
    17
    16 [10]
    16 [11]
    34
    32 [12]
    Units: Number
    arithmetic mean (standard deviation)
        Mean (SD)
    10.3 ( 12.79 )
    10.6 ( 10.48 )
    7.9 ( 10.28 )
    11.4 ( 11.94 )
    10.4 ( 11.52 )
    9.6 ( 11.11 )
    Notes
    [10] - 1 subject was withdrawn from the study, at the subject's request.
    [11] - 1 subject was withdrawn from the study, at the subject's request.
    [12] - 1 subject was withdrawn from the study, at the subject's request.
    No statistical analyses for this end point

    Secondary: The American Fertility Society Scores for Adhesions of Ovaries and Tubes (2nd Look Laparoscopy - 1st Look Laparoscopy)

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    End point title
    		 The American Fertility Society Scores for Adhesions of Ovaries and Tubes (2nd Look Laparoscopy - 1st Look Laparoscopy) [13]
    End point description
    The assessments of the overall extent and severity of adhesions as described above were used to derive American Fertility Society scores. Scores at 1st Look Laparoscopy procedure were subtracted from scores at 2nd Look Laparoscopy procedure and a difference derived in adjusted means between treatment groups.
    End point type
    Secondary
    End point timeframe
    Adhesion Assessment and Recording of Laparoscopic Examination was performed after completion of 1st laparoscopic (index) procedure and again after completion of 2nd laparoscopic procedure, 6 (+/- 4) weeks following the index procedure.
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The AFS score at 1st Look Laparoscopy were subtracted from score at 2LL and a difference was compared between treated and untreated ovaries. Adjusted means are presented separately for treated and untreated ovaries. Summary statistics are not provided separately for 1st and 2nd Look Laparoscopy for this endpoint. Note: The table below summaries data for difference in scores between 2nd Look and 1st Look Laparoscopy, with columns presented for treated ovaries, untreated ovaries, and in total.
    End point values
    		 Treated Ovary (2nd Look Laparoscopy) Untreated Ovary (2nd Look Laparoscopy) 2nd Look Laparoscopy
    Number of subjects analysed
    16 [14]
    16 [15]
    32 [16]
    Units: Number
    arithmetic mean (standard deviation)
        2LL-1LL: Mean (SD)
    -2.8 ( 9.70 )
    0.4 ( 5.21 )
    -1.2 ( 7.83 )
    Notes
    [14] - 1 subject was withdrawn from the study, at the subject's request.
    [15] - 1 subject was withdrawn from the study, at the subject's request.
    [16] - 1 subject was withdrawn from the study, at the subject's request.
    Statistical analysis title
    		 Other Efficacy analysis
    Statistical analysis description
    AFS scores was summarized by treatment at 1LL and 2LL and compared between treatments at 2LL using an analysis of covariance, with subject and treatment as factors and value at 1LL as a covariate. The difference of LS-means will be displayed as well as its 95% confidence interval and its associated p-value. The point estimate, confidence interval, and p-value shown are for the difference in adjusted means between treated and untreated ovaries with respect to difference (2LL-1LL) in AFS scores.
    Comparison groups
    Treated Ovary (2nd Look Laparoscopy) v Untreated Ovary (2nd Look Laparoscopy)
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other [17]
    P-value
    		 = 0.2341
    Method
    		 analysis of covariance
    Parameter type
    		 Difference in adjusted means
    Point estimate
    -3.245
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.822
         upper limit
    		 2.233
    Notes
    [17] - AFS Scores for Adhesions of Ovaries and Tubes (2nd Look Laparoscopy - 1st Look Laparoscopy).

    Secondary: The American Fertility Society Scores for Adhesions of Ovaries Only at 1st Look Laparoscopy and 2nd Look Laparoscopy

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    End point title
    		 The American Fertility Society Scores for Adhesions of Ovaries Only at 1st Look Laparoscopy and 2nd Look Laparoscopy
    End point description
    The American Fertility Society scoring system was also used to evaluate the extent and severity of the adhesion.
    End point type
    Secondary
    End point timeframe
    Adhesion Assessment and Recording of Laparoscopic Examination was performed after completion of 1st laparoscopic (index) procedure and again after completion of 2nd laparoscopic procedure, 6 (+/- 4) weeks following the index procedure.
    End point values
    		 Treated Ovary (1st Look Laparoscopy) Untreated Ovary (1st Look Laparoscopy) Treated Ovary (2nd Look Laparoscopy) Untreated Ovary (2nd Look Laparoscopy) 1st Look Laparoscopy 2nd Look Laparoscopy
    Number of subjects analysed
    17
    17
    16 [18]
    16 [19]
    17
    16 [20]
    Units: Number
    arithmetic mean (standard deviation)
        Mean (SD)
    6.4 ( 6.88 )
    5.6 ( 5.11 )
    4.6 ( 6.91 )
    7.1 ( 6.87 )
    6.0 ( 5.98 )
    5.8 ( 6.89 )
    Notes
    [18] - 1 subject was withdrawn from the study, at the subject's request.
    [19] - 1 subject was withdrawn from the study, at the subject's request.
    [20] - 1 subject was withdrawn from the study, at the subject's request.
    No statistical analyses for this end point

    Secondary: The American Fertility Society Scores for Adhesions of Ovaries Only (2nd Look Laparoscopy - 1st Look Laparoscopy)

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    End point title
    		 The American Fertility Society Scores for Adhesions of Ovaries Only (2nd Look Laparoscopy - 1st Look Laparoscopy) [21]
    End point description
    The assessments of the overall extent and severity of adhesions as described above were used to derive American Fertility Society scores. Scores at 1st Look Laparoscopy procedure were subtracted from scores at 2nd Look Laparoscopy procedure and a difference derived in adjusted means between treatment groups.
    End point type
    Secondary
    End point timeframe
    Adhesion Assessment and Recording of Laparoscopic Examination was performed after completion of 1st laparoscopic (index) procedure and again after completion of 2nd laparoscopic procedure, 6 (+/- 4) weeks following the index procedure.
    Notes
    [21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The AFS score at 1st Look Laparoscopy were subtracted from score at 2LL and a difference was compared between treated and untreated ovaries. Adjusted means are presented separately for treated and untreated ovaries. Summary statistics are not provided separately for 1st and 2nd Look Laparoscopy for this endpoint. Note: The table below summaries data for difference in scores between 2nd Look and 1st Look Laparoscopy, with columns presented for treated ovaries, untreated ovaries, and in total.
    End point values
    		 Treated Ovary (2nd Look Laparoscopy) Untreated Ovary (2nd Look Laparoscopy) 2nd Look Laparoscopy
    Number of subjects analysed
    16 [22]
    16 [23]
    32 [24]
    Units: Number
    arithmetic mean (standard deviation)
        2LL - 1LL: Mean (SD)
    -1.9 ( 6.49 )
    1.3 ( 4.30 )
    -0.3 ( 5.66 )
    Notes
    [22] - 1 subject was withdrawn from the study, at the subject's request.
    [23] - 1 subject was withdrawn from the study, at the subject's request.
    [24] - 1 subject was withdrawn from the study, at the subject's request.
    Statistical analysis title
    		 Other Efficacy Endpoints
    Statistical analysis description
    The American Fertility Society Scores for Adhesions of Ovaries Only at 1st Look Laparoscopy and 2nd Look Laparoscopy procedures
    Comparison groups
    Treated Ovary (2nd Look Laparoscopy) v Untreated Ovary (2nd Look Laparoscopy)
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1125
    Method
    		 Analysis of covariance
    Parameter type
    		 Difference in adjusted means
    Point estimate
    -3.049
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.904
         upper limit
    		 0.805

    Secondary: Incidence of Ovaries with Adhesions at 1st Look Laparoscopy

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    End point title
    		 Incidence of Ovaries with Adhesions at 1st Look Laparoscopy [25]
    End point description
    End point type
    Secondary
    End point timeframe
    Adhesion Assessment and Recording of Laparoscopic Examination was performed after completion of 1st laparoscopic (index) procedure.
    Notes
    [25] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is not reporting statistics for all the arms since it records the data for 1st Look Laparoscopy only.
    End point values
    		 Treated Ovary (1st Look Laparoscopy) Untreated Ovary (1st Look Laparoscopy) 1st Look Laparoscopy
    Number of subjects analysed
    17
    17
    34
    Units: subjects
        No adhesion
    6
    5
    11
        Not categorized adhesion
    11
    12
    23
        Total
    17
    17
    34
    No statistical analyses for this end point

    Secondary: Extent of Reformed Ovarian Adhesions at 2nd Look Laparoscopy

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    End point title
    		 Extent of Reformed Ovarian Adhesions at 2nd Look Laparoscopy [26]
    End point description
    Secondary Assessment of Efficacy Endpoint If an adhesion was also present (at the same site) at 1st Look Laparoscopy then the 2nd Look Laparoscopy adhesion will be considered as a reformed adhesion. If at 1st Look Laparoscopy, surgery was performed (other than adhesiolysis) at that site then the reformed adhesion is categorized as “2b”. If no surgery (other than adhesiolysis) was performed at that site then the reformed adhesion is categorized as “2a”.
    End point type
    Secondary
    End point timeframe
    Adhesion Assessment and Recording of Laparoscopic Examination was performed after completion of 2nd Look Laparoscopy procedure, 6 (+/- 4) weeks following the index procedure, in subjects who had at least one ovary with an adhesion at 1st Look Laparoscopy.
    Notes
    [26] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: the extent of reformed ovarian adhesions at 2nd Look Laparoscopy in subjects who had at least one ovary with an adhesion at 1st Look Laparoscopy. The end point is not reporting statistics for all the arms since it records the data for 2nd Look Laparoscopy.
    End point values
    		 Treated Ovary (2nd Look Laparoscopy) Untreated Ovary (2nd Look Laparoscopy) 2nd Look Laparoscopy
    Number of subjects analysed
    16 [27]
    16 [28]
    32 [29]
    Units: Adhesions
        Overall Observations
    12
    12
    24
        No reformed adhesions
    6
    3
    9
        <1/3 of surface with adhesions
    2
    2
    4
        Reformed 2a
    2
    1
    3
        Reformed 2b
    0
    1
    1
        1/3 to 2/3 of surface with adhesions
    0
    2
    2
        Reformed 2a (1/3 to 2/3)
    0
    2
    2
        Reformed 2b (1/3 to 2/3)
    0
    0
    0
        >2/3 of surface with adhesions
    4
    5
    9
        Reformed 2a (>2/3)
    4
    3
    7
        Reformed 2b (>2/3)
    0
    2
    2
    Notes
    [27] - 1 subject was withdrawn from the study, at the subject's request.
    [28] - 1 subject was withdrawn from the study, at the subject's request.
    [29] - 1 subject was withdrawn from the study, at the subject's request.
    Statistical analysis title
    		 Other Efficacy Endpoints
    Statistical analysis description
    Comparison between the extent of reformed adhesions in treated and untreated ovaries using the Wilcoxon signed rank test gave a p-value of 0.3750. Extent of Reformed Ovarian Adhesions at the extent of reformed ovarian adhesions at 2nd Look Laparoscopy, 6 (+/- 4) weeks following the index procedure in subjects who had at least one ovary with an adhesion at 1st Look Laparoscopy (index procedure).
    Comparison groups
    Treated Ovary (2nd Look Laparoscopy) v Untreated Ovary (2nd Look Laparoscopy)
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.375
    Method
    		 Wilcoxon signed rank test
    Confidence interval

    Secondary: Extent of de novo Ovarian Adhesions at 1st Look Laparoscopy

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    End point title
    		 Extent of de novo Ovarian Adhesions at 1st Look Laparoscopy [30]
    End point description
    If an adhesion was not present (at the same site) at 1LL, the 2LL adhesion will be considered as a de novo adhesion. If at 1LL, surgery was performed at that site then the de novo adhesion is categorized as “1b”. If no surgery was performed then the de novo adhesion is categorized as “1a”.
    End point type
    Secondary
    End point timeframe
    Adhesion Assessment and Recording of Laparoscopic Examination was performed after completion of 1st Look Laparoscopic (index) procedure.
    Notes
    [30] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point is not reporting statistics for all arms since it records the extent of de novo ovarian adhesions in subjects who had at least one ovary without an adhesion at 1st Look Laparoscopy.
    End point values
    		 Treated Ovary (1st Look Laparoscopy) Untreated Ovary (1st Look Laparoscopy) 1st Look Laparoscopy
    Number of subjects analysed
    17
    17
    34
    Units: Ovaries
        Overall Observations
    7
    7
    14
        No de novo adhesions
    5
    5
    10
        <1/3 of surface with adhesions
    2
    1
    3
        De novo 1a (<1/3)
    2
    1
    3
        De novo 1b (<1/3)
    0
    0
    0
        1/3 to 2/3 of surface with adhesions
    0
    1
    1
        De novo 1a (1/3 to 2/3)
    0
    1
    1
        De novo 1b (1/3 to 2/3)
    0
    0
    0
        >2/3 of surface with adhesions
    0
    0
    0
        De novo 1a ( >2/3)
    0
    0
    0
        De novo 1b ( >2/3)
    0
    0
    0
    Statistical analysis title
    		 Extent of de novo Ovarian Adhesions
    Statistical analysis description
    Extent of de novo Ovarian Adhesions
    Comparison groups
    Treated Ovary (1st Look Laparoscopy) v Untreated Ovary (1st Look Laparoscopy)
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.375
    Method
    		 Wilcoxon signed rank test
    Confidence interval

    Secondary: Incidence of Ovaries with Reformed or de novo Adhesions at 2nd Look Laparoscopy

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    End point title
    		 Incidence of Ovaries with Reformed or de novo Adhesions at 2nd Look Laparoscopy [31]
    End point description
    If an adhesion was also present (at the same site) at 1st Look Laparoscopy then the 2nd Look Laparoscopy adhesion will be considered as a reformed adhesion. If at 1st Look Laparoscopy, surgery was performed (other than adhesiolysis) at that site then the reformed adhesion is categorized as “2b”. If no surgery (other than adhesiolysis) was performed at that site then the reformed adhesion is categorized as “2a”. If an adhesion was not present (at the same site) at 1st Look Laparoscopy, the 2nd Look Laparoscopy adhesion will be considered as a de novo adhesion. If at 1st Look Laparoscopy, surgery was performed at that site then the de novo adhesion is categorized as “1b”. If no surgery was performed then the de novo adhesion is categorized as “1a”.
    End point type
    Secondary
    End point timeframe
    Adhesion Assessment and Recording of Laparoscopic Examination was performed after completion of 2nd laparoscopic procedure, 6 (+/- 4) weeks following the index procedure.
    Notes
    [31] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The incidence of ovaries with reformed or de novo adhesions at 2nd Look Laparoscopy is summarised. This end point is not reporting statistics for all the arms since it records the data for 2nd Look Laparoscopy only.
    End point values
    		 Treated Ovary (2nd Look Laparoscopy) Untreated Ovary (2nd Look Laparoscopy) 2nd Look Laparoscopy
    Number of subjects analysed
    16 [32]
    16 [33]
    32 [34]
    Units: Subjects
        No adhesion
    8
    5
    13
        De novo a1
    2
    2
    4
        Reformed 2a
    6
    6
    12
        Reformed 2b
    0
    3
    3
        Total
    16
    16
    32
    Notes
    [32] - 1 subject was withdrawn from the study, at the subject's request.
    [33] - 1 subject was withdrawn from the study, at the subject's request.
    [34] - 1 subject was withdrawn from the study, at the subject's request.
    No statistical analyses for this end point

    Secondary: Severity of Reformed Ovarian Adhesions at 2nd Look Laparoscopy

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    End point title
    		 Severity of Reformed Ovarian Adhesions at 2nd Look Laparoscopy [35]
    End point description
    End point type
    Secondary
    End point timeframe
    The extent of reformed ovarian adhesions assessment after completion of 2nd Look Laparoscopic procedure, 6 (+/- 4) weeks following the index procedure, in subjects who had at least one ovary with an adhesion at 1st Look Laparoscopy (index procedure).
    Notes
    [35] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The severity of reformed ovarian adhesions in subjects who had at least one ovary with an adhesion at 1st Look Laparoscopy is summarized and comparison between the severity of reformed adhesions in treated and untreated ovaries was made.
    End point values
    		 Treated Ovary (2nd Look Laparoscopy) Untreated Ovary (2nd Look Laparoscopy) 2nd Look Laparoscopy
    Number of subjects analysed
    16 [36]
    16 [37]
    32 [38]
    Units: Adhesion
        Overall Observations
    12
    12
    24
        No reformed adhesions
    6
    3
    9
        Filmy, avascular
    1
    0
    1
        Reformed 2a (Filmy, avascular)
    1
    0
    1
        Reformed 2b (Filmy, avascular)
    0
    0
    0
        Dense and/or vascular
    1
    2
    3
        Reformed 2a (Dense and/or vascular)
    1
    2
    3
        Reformed 2b (Dense and/or vascular)
    0
    0
    0
        Cohesive
    4
    7
    11
        Reformed 2a (Cohesive)
    4
    4
    8
        Reformed 2b (Cohesive)
    0
    3
    3
    Notes
    [36] - 1 subject was withdrawn from the study, at the subject's request.
    [37] - 1 subject was withdrawn from the study, at the subject's request.
    [38] - 1 subject was withdrawn from the study, at the subject's request.
    Statistical analysis title
    		 Other Efficacy Analysis
    Statistical analysis description
    Severity of Reformed Ovarian Adhesions
    Comparison groups
    Untreated Ovary (2nd Look Laparoscopy) v Treated Ovary (2nd Look Laparoscopy)
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.3438
    Method
    		 Wilcoxon signed rank test
    Confidence interval

    Secondary: Severity of de novo Ovarian Adhesions at 1st Look Laparoscopy

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    End point title
    		 Severity of de novo Ovarian Adhesions at 1st Look Laparoscopy [39]
    End point description
    If an adhesion was not present (at the same site) at 1LL, the 2LL adhesion will be considered as a de novo adhesion. If at 1LL, surgery was performed at that site then the de novo adhesion is categorized as “1b”. If no surgery was performed then the de novo adhesion is categorized as “1a”.
    End point type
    Secondary
    End point timeframe
    Adhesion Assessment and Recording of Laparoscopic Examination was performed after completion of 1st Look Laparoscopic (index) procedure.
    Notes
    [39] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point is not reporting statistics for all arms since it records the severity of de novo ovarian adhesions in subjects who had at least one ovary without an adhesion at 1st Look Laparoscopy.
    End point values
    		 Treated Ovary (1st Look Laparoscopy) Untreated Ovary (1st Look Laparoscopy) 1st Look Laparoscopy
    Number of subjects analysed
    17
    17
    34
    Units: Ovaries
        Overall Observations
    7
    7
    14
        No de novo adhesions
    5
    5
    10
        Filmy, avascular
    1
    1
    2
        De novo 1a (Filmy, avascular)
    1
    1
    2
        De novo 1b (Filmy, avascular)
    0
    0
    0
        Dense and/or vascular
    0
    1
    1
        De novo 1a (Dense and/or vascular)
    0
    1
    1
        De novo 1b (Dense and/or vascular)
    0
    0
    0
        Cohesive
    1
    0
    1
        De novo 1a (Cohesive)
    1
    0
    1
        De novo 1b (Cohesive)
    0
    0
    0
    Statistical analysis title
    		 Severity of de novo Ovarian Adhesions
    Statistical analysis description
    Severity of de novo Ovarian Adhesions
    Comparison groups
    Treated Ovary (1st Look Laparoscopy) v Untreated Ovary (1st Look Laparoscopy)
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 1
    Method
    		 Wilcoxon signed rank test
    Confidence interval

    Secondary: Incidence of Ovarian Adhesions by Presence of Endometriosis at 1st Look Laparoscopy and 2nd Look Laparoscopy

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    End point title
    		 Incidence of Ovarian Adhesions by Presence of Endometriosis at 1st Look Laparoscopy and 2nd Look Laparoscopy
    End point description
    Analysis of the incidence of adhesions in treated and untreated ovaries according to whether or not endometriosis was present at 1st look laparoscopy and again at 2nd look laparoscopy.
    End point type
    Secondary
    End point timeframe
    Adhesion Assessment and Recording of Laparoscopic Examination was performed after completion of 1st look laparoscopic (index) procedure and again after completion of 2nd look laparoscopic procedure, 6 (+/- 4) weeks following the index procedure.
    End point values
    		 Treated Ovary (1st Look Laparoscopy) Untreated Ovary (1st Look Laparoscopy) Treated Ovary (2nd Look Laparoscopy) Untreated Ovary (2nd Look Laparoscopy) 1st Look Laparoscopy 2nd Look Laparoscopy
    Number of subjects analysed
    17
    17
    16 [40]
    16 [41]
    34
    32 [42]
    Units: Ovaries with Adhesion
        Absence of Adhesion (a)
    3
    3
    5
    4
    6
    9
        Presence of Adhesion (a)
    3
    3
    8
    9
    6
    17
        Absence of Endometriosis (Total)
    6
    6
    13
    13
    12
    26
        Absence of Adhesion (b)
    2
    2
    1
    1
    5
    2
        Presence of Adhesion (b)
    8
    9
    2
    2
    17
    4
        Presence of Endometriosis (Total)
    11
    11
    3
    3
    22
    6
    Notes
    [40] - 1 subject was withdrawn from the study, at subject's request.
    [41] - 1 subject was withdrawn from the study, at subject's request.
    [42] - 1 subject was withdrawn from the study, at subject's request.
    No statistical analyses for this end point

    Other pre-specified: Incidence of Adhesions at various Anatomical Sites

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    End point title
    		 Incidence of Adhesions at various Anatomical Sites
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Adhesion Assessment and Recording of Laparoscopic Examination was performed at after completion of 1st laparoscopic (index) procedure and again after completion of 2nd laparoscopic procedure, 6 (+/- 4) weeks following the index procedure.
    End point values
    		 1st Look Laparoscopy 2nd Look Laparoscopy
    Number of subjects analysed
    17
    16 [43]
    Units: Subjects
        Anterior abdominal wall above incision site
    1
    0
        Anterior abdominal wall incision site
    7
    4
        Large bowel
    12
    7
        Left anterior abdominal wall
    1
    2
        Left anterior cul-de-sac
    2
    2
        Left pelvic sidewall
    6
    6
        Left posterior broad ligament
    13
    15
        Left round ligament to tube
    1
    4
        Left Tube
    6
    8
        Omentum
    4
    1
        Over bladder in anterior cul-de-sac
    3
    2
        Over uterus in anterior cul-de-sac
    4
    2
        Posterior cul-de-sac
    7
    4
        Posterior uterus
    10
    9
        Right anterior abdominal wall
    1
    1
        Right anterior cul-de-sac
    1
    1
        Right pelvic sidewall
    9
    5
        Right posterior broad ligament
    13
    10
        Right round ligament to tube
    2
    2
        Right Tube
    9
    8
        Small bowel
    2
    3
    Notes
    [43] - 1 subject was withdrawn from the study, at the subject's request.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All Adverse Events (AE) (serious and non serious) occurring from the date the patient signed informed consent until 30 days following the second-look control laparoscopy, was recorded.
    Adverse event reporting additional description
    An adverse event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Serious adverse events
    		 Overall Trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 17 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Overall Trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 17 (82.35%)
    Injury, poisoning and procedural complications
    Foot fracture
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Paraesthesia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    General disorders and administration site conditions
    Feeling hot
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Impaired healing
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Pain
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Pyrexia
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    7 / 17 (41.18%)
         occurrences all number
    7
    Nausea
         subjects affected / exposed
    3 / 17 (17.65%)
         occurrences all number
    3
    Toothache
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    4 / 17 (23.53%)
         occurrences all number
    4
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    3 / 17 (17.65%)
         occurrences all number
    3
    Vulvovaginal pruritus
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Renal and urinary disorders
    Renal pain
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Musculoskeletal pain
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Infections and infestations
    Cystitis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Gingival abscess
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Kidney infection
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Oral herpes
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Pharyngitis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Sinusitis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Subcutaneous abscess
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Jul 2007
    Amendments Requested by Spain Version ‘Final 2.0 Amendment 1.1’, dated 6 July 2007, incorporated the following changes: • It was clarified that the 2LL visit would only be performed if it was the investigator's opinion that this second look was in the best interest of the subject. • Physical examination and measurement of vital signs added to the baseline visit. • Gynecological examination was included in the physical examination at the screening visit and at the "within 72 hours prior to 2LL visit." • It was clarified that the elective surgery to be undertaken was to be for subjects with known or suspected bilateral ovarian disease. • It was clarified that in the case of a device malfunction, a replacement kit of Adhexil™ could be used. In this situation the total amount of Adhexil™ applied should be approximately 10 mL. • The observation period following initial application of Adhexil™ was extended from 2 minutes to 15 minutes to allow the investigator to assess whether a layer of Adhexil™ had been formed. In addition, it was instructed that during this observation period an air flow was to be maintained to allow the treated surfaces to dry. • The text in the subject information sheet was changed from " Adhexil™ and both laparoscopic procedures will be provided to you free of charge." to read " Adhexil™ and all study specific procedures including the second laparoscopic procedure will be provided to you free of charge."
    17 Jul 2007
    Amendments Requested by Germany Version ‘Final 2.0 Amendment 2’, dated 17 July 2007, incorporated the following changes: • The provision for unopened vials of Adhexil™ to be left at room temperature for up to 24 hours was deleted. • The protocol statement that the investigational product, once aspirated into the application device, was to be used within 4 hours was changed to state that the product was to be used immediately.
    02 Oct 2007
    Version ‘Final 2.0 IRB Amendment’, dated 02 October 2007, incorporated the following changes: • The title of the protocol was changed to "A prospective controlled randomized, multicenter exploratory pilot study evaluating the safety and potential trends in efficacy of Adhexil™ " • An inclusion criterion was added: "Patients with American Society of Anesthesiologists class I (excluding those with a risk of anesthesia complications or those with hypertension)."

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    16 Jul 2008
    PREMATURE TERMINATION OF THE STUDY The study planned to enroll 25 subjects. However, recruitment was much slower than anticipated due to the relatively small number of patients with bilateral ovarian disease and thus a decision was taken to terminate the study after inclusion of 17 subjects.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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