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    Clinical Trial Results:
    Bronchoscopic indocyanine green fluorescence imaging for the evaluation of tracheal perfusion after surgery

    Summary
    EudraCT number
    		 2013-001725-10
    Trial protocol
    		 AT  
    Global end of trial date
    01 Aug 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Sep 2020
    First version publication date
    24 Sep 2020
    Other versions
    Summary report(s)
    		 Publication_ATS

    Trial information

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    Trial identification
    Sponsor protocol code
    13-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medizinische Universität Wien
    Sponsor organisation address
    Spitalgasse 23, Vienna, Austria,
    Public contact
    Department für Chirurgie, Medizinische Universität Wien, 0043 1404006979, konrad.hoetzenecker@meduniwien.ac.at
    Scientific contact
    Department für Chirurgie, Medizinische Universität Wien, 0043 1404006979, konrad.hoetzenecker@meduniwien.ac.at
    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
    01 Aug 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Jul 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Aug 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Anastomotic complications state a serious problem in tracheal surgery. However, conventional bronchoscopy is the only available modality to directly observe the perfusion of the anastomotic site. Aim of this study is to show that the procedure of ICG bronchoscopy is feasible. In the future, ICG bronchoscopy might help to identify patients with impaired perfusion at the anastomotic site earlier and guide the surgeon in the further management of such patients.
    Protection of trial subjects
    Contraindications for the application of ICG have to be exluded in advance. The patients will be observed for at least 1.5 hours after application for any acute drug-related AE. The obtained data will be stored anonymized and locked.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Nov 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 12
    Worldwide total number of subjects
    12
    EEA total number of subjects
    12
    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)
    7
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 All patients receiving elective laryngotracheal surgery at the Division of Thoracic Surgery, Medical University Vienna and patients

    Pre-assignment
    Screening details
    		 -informed-consent to participate -exclusion of allergy to iodide

    Period 1
    Period 1 title
    Measurements (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Open-label feasibility

    Arms
    Arm title
    		 Feasibility
    Arm description
    		 Feasibility of ICG bronchoscopy
    Arm type
    		 Experimental

    Investigational medicinal product name
    INDOCYANINE GREEN
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    0.3mg per kg bodyweight via a peripheral venous catheter

    Number of subjects in period 1
    		Feasibility
    Started
    12
    Completed
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Measurements
    Reporting group description
    		 -

    Reporting group values
    		 Measurements Total
    Number of subjects
    		 12 12
    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)
    		 7 7
        From 65-84 years
    		 5 5
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 57 (29 to 75) -
    Gender categorical
    Units: Subjects
        Female
    		 5 5
        Male
    		 7 7
    Subject analysis sets

    Subject analysis set title
    Final analysis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Final analysis of all patients (n=12)

    Subject analysis set title
    Measurement intra-op
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Performed intraoperative measurements

    Subject analysis set title
    Measurement before hospital discharge
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Performed measurements before hospital discharge

    Subject analysis set title
    Follow-up
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Final measurement 2 months after surgery

    Subject analysis sets values
    		 Final analysis Measurement intra-op Measurement before hospital discharge Follow-up
    Number of subjects
    12
    11
    11
    10
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
    0
        Adults (18-64 years)
    7
    6
    6
    7
        From 65-84 years
    5
    5
    5
    3
        85 years and over
    0
    0
    0
    0
    Age continuous
    Units: years
        median (full range (min-max))
    57 (29 to 75)
    61 (29 to 75)
    61 (29 to 75)
    51 (29 to 74)
    Gender categorical
    Units: Subjects
        Female
    5
        Male
    7

    End points

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    End points reporting groups
    Reporting group title
    Feasibility
    Reporting group description
    		 Feasibility of ICG bronchoscopy

    Subject analysis set title
    Final analysis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Final analysis of all patients (n=12)

    Subject analysis set title
    Measurement intra-op
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Performed intraoperative measurements

    Subject analysis set title
    Measurement before hospital discharge
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Performed measurements before hospital discharge

    Subject analysis set title
    Follow-up
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Final measurement 2 months after surgery

    Primary: Successful visualization of ICG flourescence

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    End point title
    		 Successful visualization of ICG flourescence [1]
    End point description
    End point type
    Primary
    End point timeframe
    Immediately after ICG injection
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Feasibilty study. Please see attached publication.
    End point values
    		 Final analysis
    Number of subjects analysed
    Units: ICG fluorescence signal
    12
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Time from surgery until last follow-up
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Feasibility
    Reporting group description
    		 Feasibility of ICG bronchoscopy

    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: In this trial with a rather limited number of patients, no non-serious adverse-event occured. One patient died during follow-up due to sudden cardiac death (as listed in the serious adverse event section).
    Serious adverse events
    		 Feasibility
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 12 (8.33%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    Cardiac disorders
    Sudden cardiac death at home
    Additional description: Found dead at home two months after last study-related procedure/surgery. Previously known atrial fibrillation.
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Feasibility
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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