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    Clinical Trial Results:
    Novel Imaging of the Eustachian Tube, a CT study using dilute iodixanol in an adult population

    Summary
    EudraCT number
    		 2014-003614-87
    Trial protocol
    		 NO  
    Global end of trial date
    30 Jun 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Jul 2021
    First version publication date
    03 Jul 2021
    Other versions
    Summary report(s)
    		 Published article

    Trial information

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    Trial identification
    Sponsor protocol code
    ET31068
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02282540
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Oslo University Hospital
    Sponsor organisation address
    Sognsvannsveien 20, Oslo, Norway, 0424
    Public contact
    Dep. of Radiology and Nuclear Med., Oslo University Hospital, Rikshospitalet, ehopp@ous-hf.no
    Scientific contact
    Dep. of Radiology and Nuclear Med., Oslo University Hospital, Rikshospitalet, ehopp@ous-hf.no
    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 Dec 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jun 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To diagnose dysfunction in the eustachian tube by injecting an iodine based contrast medium into the middle ear followed by CT imaging
    Protection of trial subjects
    Calm examination environment. thorough information. Local anesthesia. Follow up
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 May 2015
    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
    Norway: 23
    Worldwide total number of subjects
    23
    EEA total number of subjects
    23
    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)
    23
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Adults. OME diagnosis seeking treatment 2015-2017. Living in Southern Norway Controls: adults, healthy middle ears

    Pre-assignment
    Screening details
    		 Adult patients with OME who were subject for balloon dilation of the Eustachian tube. no known allergies towards contrast media Controls chosen from a mb Meniere group because they were subject for middle ear drainage

    Pre-assignment period milestones
    Number of subjects started
    		 23
    Number of subjects completed
    		 23

    Period 1
    Period 1 title
    pre procedure clinical examination
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 patient group
    Arm description
    		 Patients With OME referred for Balloon dilation. Inclusion.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 control group
    Arm description
    		 mb meniere patients who were thought to benefit from tympanostomy
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		patient group control group
    Started
    18
    5
    Completed
    18
    5
    Period 2
    Period 2 title
    Procedure
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Patient group
    Arm description
    		 OME patients
    Arm type
    		 Experimental

    Investigational medicinal product name
    Visipaque
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intratympanic use
    Dosage and administration details
    a 20% iodixanol (VisipaqueTM 320 mg/mL) solution diluted with saline (NaCl 9 mg/mL), was slowly injected into the middle ear through the tympanostomy tube using a 22-G suction needle until the middle ear was filled up, but not expanded. The amount given was approximately 0.5 ml.

    Arm title
    		 Control group
    Arm description
    		 Mb Meniere, no middle ear disease
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Visipaque
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intratympanic use
    Dosage and administration details
    a 20% iodixanol (VisipaqueTM 320 mg/mL) solution diluted with saline (NaCl 9 mg/mL), was slowly injected into the middle ear through the tympanostomy tube using a 22-G suction needle until the middle ear was filled up, but not expanded. The amount given was approximately 0.5 ml.

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: Period 1 is the inclusion period without intervention. The Product was given only once in period 2 in both arms
    Number of subjects in period 2
    		Patient group Control group
    Started
    18
    5
    Completed
    17
    5
    Not completed
    1
    0
         Protocol deviation
    1
    -
    Period 3
    Period 3 title
    Four -six month follow up
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Patient group
    Arm description
    		 follow up of OME patients
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Control group
    Arm description
    		 mb Meniere
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 3
    		Patient group Control group
    Started
    17
    5
    Completed
    17
    5

    Baseline characteristics

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

    Reporting group values
    		 Procedure Total
    Number of subjects
    		 23 23
    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)
    		 23 23
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 50 (18 to 64) -
    Gender categorical
    Units: Subjects
        Female
    		 12 12
        Male
    		 11 11

    End points

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    End points reporting groups
    Reporting group title
    patient group
    Reporting group description
    		 Patients With OME referred for Balloon dilation. Inclusion.

    Reporting group title
    control group
    Reporting group description
    		 mb meniere patients who were thought to benefit from tympanostomy
    Reporting group title
    Patient group
    Reporting group description
    		 OME patients

    Reporting group title
    Control group
    Reporting group description
    		 Mb Meniere, no middle ear disease
    Reporting group title
    Patient group
    Reporting group description
    		 follow up of OME patients

    Reporting group title
    Control group
    Reporting group description
    		 mb Meniere

    Primary: Contrast medium passage

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    End point title
    		 Contrast medium passage [1]
    End point description
    Visual assessment at CT examination
    End point type
    Primary
    End point timeframe
    10 minutes after contrast medium administration
    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: Study number was too small for statistical analysis in this feasibility study
    End point values
    		 Patient group Control group
    Number of subjects analysed
    14 [2]
    5
    Units: individuals
        Cartilaginous Eustachian tube
    2
    2
        Bony Eustachian tube
    8
    0
        Epipharynx
    4
    3
    Notes
    [2] - three did not have passage to the Eustachian tube at all, and one was excluded
    No statistical analyses for this end point

    Secondary: Middle ear inflammation

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    End point title
    		 Middle ear inflammation
    End point description
    Mucous membrane inspection by otoscopy
    End point type
    Secondary
    End point timeframe
    At time of contrast medium administration, four-six months after administration
    End point values
    		 Patient group Control group
    Number of subjects analysed
    17
    5
    Units: individuals
        inflammation
    0
    0
        no inflammation
    17
    5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    2015-2017
    Adverse event reporting additional description
    clinical observation and patient reporting
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Patient group
    Reporting group description
    		 OME patients subject to contrast medium administration in the middle ear

    Reporting group title
    Control group
    Reporting group description
    		 Control group subject to contrast medium administration in the middle ear

    Serious adverse events
    		 Patient group Control group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 5 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 4%
    Non-serious adverse events
    		 Patient group Control group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 5 (20.00%)
    Ear and labyrinth disorders
    Dizziness
    Additional description: One of the control patients reported transient dizziness during CM administration. Dizziness was classified as an expected AE in the study protocol. The symptoms resolved before the examination was over for this particular patient and we assumed
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1

    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.
    Low number of inclusion in both arms. Audiometry not part of the study

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/32030198
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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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