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    Clinical Trial Results:
    A Randomized Controlled Non-inferiority Study to Evaluate the Efficacy and Safety of Hemopatch Compared to TachoSil in Preventing or Reducing Postoperative Air Leaks After Pulmonary Resection.

    Summary
    EudraCT number
    2017-003931-12
    Trial protocol
    CZ   ES   IT  
    Global end of trial date
    09 Jul 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    14 Oct 2020
    First version publication date
    14 Oct 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BXU513667
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03450265
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Baxter Healthcare
    Sponsor organisation address
    1 Baxter Pkwy, Deerfield, United States, 60015
    Public contact
    Sr Clinical Project Manager, Baxter R&D Europe SPRL, 224 948-7359, Global_CORP_ClinicalTrialsDisclosure@baxter.com
    Scientific contact
    Sr Clinical Project Manager, Baxter R&D Europe SPRL, 224 948-7359, Global_CORP_ClinicalTrialsDisclosure@baxter.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
    31 Jan 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Jul 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Jul 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of Hemopatch compared to TachoSil in postoperative air leak duration after pulmonary resection.
    Protection of trial subjects
    The DSMB reviewed safety and efficacy data from the study at the following data cutoffs (1) after 50% of subjects experienced a post-operative air leak, had been completed or withdrawn and (2) study completion.
    Background therapy
    -
    Evidence for comparator
    In a study conducted by Filosso et al (2013)2, TachoSil sealant was found to be superior to standard stapling and suturing aerostatic techniques in reducing post-operative air leaks.
    Actual start date of recruitment
    25 Jun 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 74
    Country: Number of subjects enrolled
    Italy: 95
    Worldwide total number of subjects
    169
    EEA total number of subjects
    169
    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)
    63
    From 65 to 84 years
    106
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    -

    Pre-assignment period milestones
    Number of subjects started
    279 [1]
    Number of subjects completed
    169

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    Pre-operative Screen Failures: 19
    Reason: Number of subjects
    Randomized with Intra-operative Screen Failures: 91
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Subjects captured in pre-assignment period include (1) pre-operative screen failures and (2) randomized with intra-operative screen failures. Only those that completed pre-assignment were randomized as intra-operative eligible and provided study treatment.
    Period 1
    Period 1 title
    Randomized, Intra-Operative Eligibility (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Single blind
    Roles blinded
    Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Hemopatch
    Arm description
    Patients undergo elective pulmonary resection. Following resection, primary stapling and suturing will be done and air leakage will be assessed. If a specific grade-level of air leakage is present, patients will be randomized and Hemopatch applied.
    Arm type
    Experimental

    Investigational medicinal product name
    Hemopatch
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sealant matrix
    Routes of administration
    Soft tissue use
    Dosage and administration details
    The appropriate size of the pad was selected so that it overlapped the margins of the wound surface by about 1 cm. The size of the patches used for the study was 45 x 90 mm. It was permitted to cut the pad to the desired size and shape. According to the IFU, a maximum of 7 HEMOPATCH 45 x 90 mm patches can be used in adults.

    Arm title
    TachoSil
    Arm description
    Patients undergo elective pulmonary resection. Following resection, primary stapling and suturing will be done and air leakage will be assessed. If a specific grade-level of air leakage is present, patients will be randomized and TachoSil applied.
    Arm type
    Active comparator

    Investigational medicinal product name
    TachoSil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sealant matrix
    Routes of administration
    Soft tissue use
    Dosage and administration details
    TachoSil was applied according to the summary of product characteristics.

    Number of subjects in period 1
    Hemopatch TachoSil
    Started
    87
    82
    Completed
    83
    81
    Not completed
    4
    1
         Consent withdrawn by subject
    1
    -
         Adverse event, non-fatal
    1
    -
         Lost to follow-up
    1
    1
         Protocol deviation
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Hemopatch
    Reporting group description
    Patients undergo elective pulmonary resection. Following resection, primary stapling and suturing will be done and air leakage will be assessed. If a specific grade-level of air leakage is present, patients will be randomized and Hemopatch applied.

    Reporting group title
    TachoSil
    Reporting group description
    Patients undergo elective pulmonary resection. Following resection, primary stapling and suturing will be done and air leakage will be assessed. If a specific grade-level of air leakage is present, patients will be randomized and TachoSil applied.

    Reporting group values
    Hemopatch TachoSil Total
    Number of subjects
    87 82 169
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    65.4 ± 10.03 66.2 ± 8.72 -
    Gender categorical
    Units: Subjects
        Female
    38 29 67
        Male
    49 53 102

    End points

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    End points reporting groups
    Reporting group title
    Hemopatch
    Reporting group description
    Patients undergo elective pulmonary resection. Following resection, primary stapling and suturing will be done and air leakage will be assessed. If a specific grade-level of air leakage is present, patients will be randomized and Hemopatch applied.

    Reporting group title
    TachoSil
    Reporting group description
    Patients undergo elective pulmonary resection. Following resection, primary stapling and suturing will be done and air leakage will be assessed. If a specific grade-level of air leakage is present, patients will be randomized and TachoSil applied.

    Primary: Duration of postoperative air leakage

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    End point title
    Duration of postoperative air leakage
    End point description
    Duration was calculated as date/time of end of air leak minus date/time of end of surgery. Number of subjects included only subjects with a calculable post-operative air leak duration. The predicted mean for post-operative air leak duration was produced by an ANOVA with post-operative air leak duration as the response variable and with site, final air leak grade, type of surgery performed, and treatment as fixed effects.
    End point type
    Primary
    End point timeframe
    Day 1 to Day 30
    End point values
    Hemopatch TachoSil
    Number of subjects analysed
    83
    81
    Units: Days
        arithmetic mean (confidence interval 95%)
    3.5 (1.7 to 5.4)
    2.7 (0.8 to 4.7)
    Statistical analysis title
    Stats
    Comparison groups
    Hemopatch v TachoSil
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [1]
    P-value
    = 0.4275
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    0.81
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.2
         upper limit
    2.82
    Notes
    [1] - Based on published data a non-inferiority margin was calculated. In order to show non-inferiority, the upper limit of the 95% two-sided CI around the difference in predicted means needed to be below 1.2 days.

    Secondary: Number of Subjects with Intra-operative Treatment Failure

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    End point title
    Number of Subjects with Intra-operative Treatment Failure
    End point description
    A subject was considered a treatment failure if rescue treatment occurred. Rescue treatment could include any surgical technique or sealant (fibrin or non-fibrin), except TachoSil in subjects randomized to TachoSil.
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    Hemopatch TachoSil
    Number of subjects analysed
    87
    82
    Units: Subjects
    0
    2
    No statistical analyses for this end point

    Secondary: Number of Subjects with Prolonged Air Leaks > 5 days

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    End point title
    Number of Subjects with Prolonged Air Leaks > 5 days
    End point description
    Prolonged air leaks prolong the need for chest tube, which is associated with pain, reduced mobility and may lead to further complications. Air leak control and reducing its occurrence can have positive outcomes for the subjects including those being mobilized from bed sooner post-surgery, achieving correct and efficient respiratory function, as well as shortening the time until chest tube removal and the overall length of hospital stay.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 30
    End point values
    Hemopatch TachoSil
    Number of subjects analysed
    87
    82
    Units: Subjects
    14
    11
    No statistical analyses for this end point

    Secondary: Number of Subjects achieving Hemostasis After Application of Product

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    End point title
    Number of Subjects achieving Hemostasis After Application of Product
    End point description
    Hemostasis is the act of restricting or stopping blood flow from a damaged vessel or organ.
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    Hemopatch TachoSil
    Number of subjects analysed
    87
    82
    Units: Subjects
    87
    82
    No statistical analyses for this end point

    Secondary: Number of Subjects having the need for additional procedures

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    End point title
    Number of Subjects having the need for additional procedures
    End point description
    Type of procedures include chest drainage, re-operation, respiratory assistance, and blood transfusion.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 30
    End point values
    Hemopatch TachoSil
    Number of subjects analysed
    87
    82
    Units: Subjects
    12
    5
    No statistical analyses for this end point

    Secondary: Time to Chest Tube Removal

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    End point title
    Time to Chest Tube Removal
    End point description
    Calculated as date/time of chest tube removal minus date/time of end of surgery.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 30
    End point values
    Hemopatch TachoSil
    Number of subjects analysed
    87
    82
    Units: Days
        arithmetic mean (standard deviation)
    5.73 ± 7.067
    5.13 ± 5.731
    No statistical analyses for this end point

    Secondary: Time in surgery

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    End point title
    Time in surgery
    End point description
    Calculated as date/time of last skin suture minus date/time of first skin incision.
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    Hemopatch TachoSil
    Number of subjects analysed
    87
    82
    Units: Minutes
        arithmetic mean (standard deviation)
    155 ± 77.7
    164 ± 67.8
    No statistical analyses for this end point

    Secondary: Length of Stay in Hospital

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    End point title
    Length of Stay in Hospital
    End point description
    Calculated as (date of hospital discharge minus date of hospital admission) + 1.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 30
    End point values
    Hemopatch TachoSil
    Number of subjects analysed
    87
    82
    Units: Days
        arithmetic mean (standard deviation)
    8.52 ± 6.075
    8.01 ± 5.815
    No statistical analyses for this end point

    Secondary: Number of Unplanned Interventions

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    End point title
    Number of Unplanned Interventions
    End point description
    Additional procedures.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 30
    End point values
    Hemopatch TachoSil
    Number of subjects analysed
    87
    82
    Units: Interventions
        median (inter-quartile range (Q1-Q3))
    1 (1 to 2)
    1 (1 to 3)
    No statistical analyses for this end point

    Secondary: Number of Subjects with Treatment Emergent Adverse Events of Special Interest

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    End point title
    Number of Subjects with Treatment Emergent Adverse Events of Special Interest
    End point description
    Pre-defined post-operative adverse events of special interest (AESIs) up to 30 ± 3 days after surgery: may include pneumothorax, bronchopleural fistula, emphysema (subcutaneous and mediastinal), pleural effusions, post-operative respiratory failure, empyema, and allergic reactions in reasonable temporal relationship with the product application.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 30
    End point values
    Hemopatch TachoSil
    Number of subjects analysed
    87
    82
    Units: Subjects
        Post-operative Respiratory Failure
    0
    2
        Bronchopleural Fistula
    0
    1
        Pneumothorax
    1
    5
        Subcutaneous Emphysema
    4
    3
    No statistical analyses for this end point

    Secondary: Number of patches used

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    End point title
    Number of patches used
    End point description
    Intra-operatively.
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    Hemopatch TachoSil
    Number of subjects analysed
    87
    82
    Units: Patches
        median (inter-quartile range (Q1-Q3))
    1 (1 to 1)
    1 (1 to 1)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Day 1 to Day 30
    Adverse event reporting additional description
    Treatment Emergent AE/SAE's were reported.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20
    Reporting groups
    Reporting group title
    Hemopatch
    Reporting group description
    Patients undergo elective pulmonary resection. Following resection, primary stapling and suturing will be done and air leakage will be assessed. If a specific grade-level of air leakage is present, patients will be randomized and Hemopatch applied. Treatment-Emergent AE's reported. Non-serious AE's reflect frequency threshold.

    Reporting group title
    TachoSil
    Reporting group description
    Patients undergo elective pulmonary resection. Following resection, primary stapling and suturing will be done and air leakage will be assessed. If a specific grade-level of air leakage is present, patients will be randomized and TachoSil applied. Treatment-Emergent AE's reported. Non-serious AE's reflect frequency threshold.

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: There were no treatment emergent non-serious Adverse Events with 5% or more frequency.
    Serious adverse events
    Hemopatch TachoSil
    Total subjects affected by serious adverse events
         subjects affected / exposed
    17 / 87 (19.54%)
    6 / 82 (7.32%)
         number of deaths (all causes)
    2
    0
         number of deaths resulting from adverse events
    2
    0
    Injury, poisoning and procedural complications
    Postoperative respiratory failure
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Bronchopleural fistula
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chylothorax
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemothorax
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung hernia
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 87 (0.00%)
    2 / 82 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary air leakage
         subjects affected / exposed
    5 / 87 (5.75%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    2 / 87 (2.30%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Skin and subcutaneous tissue disorders
    Subcutaneous emphysema
         subjects affected / exposed
    3 / 87 (3.45%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    2 / 87 (2.30%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 87 (1.15%)
    3 / 82 (3.66%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tuberculosis
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Hemopatch TachoSil
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 82 (0.00%)

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Aug 2017
    • Addition of hemostasis as a secondary endpoint • Addition of reference that for target sites that are dry, the tissue can be moistened with Sodium Bicarbonate solution. • Removal of HbA1c test from End of Study Visit
    26 Oct 2017
    • Sample size was decreased to account for correct assumptions. It was originally assumed that 35% of subjects were expected to not experience a post-operative air leak, which was corrected to 5%. Originally it was planned to screen 326 subjects to randomize and treat 240 subjects. This was updated to screen 278 subjects to randomize 166 subjects. The cap of randomized subjects following the interim analysis was originally 300 subjects, which was updated to 250 subjects.
    02 Nov 2017
    • Changed digital CT drainage to CT drainage system to allow for both traditional and digital drainage systems. • Addition of stratification according to approach to surgery used (open or VATS). • Removal of reference to X-Rays which was performed according to hospital standards at the discretion of the investigator.
    13 Feb 2018
    • Alignment of study scheme with updates to study procedure. • Clarification that CT will be managed as per standard of care. • Removal of restriction of oral measurement to take temperature • Addition of a description of surgery and air leak monitoring • Clarification of the exclusion criterion of florid infection as active and removing chronic steroid use as an exclusion criterion. • Removal of capping strategy on randomization and 2:1:1 allocation of randomized subjects across surgery typed (lobectomy: segmentectomy: wedge resection). • Addition of fibrinogen to the clinical laboratory tests • Laboratory tests were moved from Visit 4 (Day 4) to Visit 3 (Day 3).
    02 May 2018
    • Clarification that Visit 4, Visit 5, and Visit 6 were only to be done if the subjects had not yet been discharged. • A note that duration of post-operative air leak was to be monitored and recorded as well as time to CT removal. If these 2 events were at different times, this was required to be documented to ensure accuracy and efficiency. If post-operative air leak persisted, subjects may have been discharged with a Heimlich valve only after observing for at least 5 days post-operatively, indicating these subjects had PAL.
    07 Jan 2019
    • Update to description of the analysis sets. For all efficacy analyses, the FAS was used as the primary analysis, while the PPS was used as supportive analysis. There were 2 main reasons for this change. Firstly, the sample size calculation did not indicate any stipulation to allow for extra recruitment of subjects to account for subjects falling out of the primary analysis set due to protocol deviations. As such, to achieve the correct sample size for the primary analysis, the FAS was used. Secondly, the nature of PPS was such that it had an inherent bias for the treatment groups as it attempted to create a ‘perfect’ subset of the population for whom the medical device was administered. To prevent such a bias from influencing the results, the FAS was preferred for the primary analysis set. • Clarification that appropriate rules to restart the study were outlined in the Data Safety Monitoring Board charter.
    12 Jun 2019
    Sponsor’s Legal Representative and Medical Monitor were updated.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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