Imaging of the Auditory tube

Phase 1

• Conditions: Otitis media With effusion; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2014-003614-87-NO
• Lead Sponsor: Oslo University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-11
• Study Completion: 2017-06-30
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

-patient > 18 years
-reffered to ENT clinic at our hospital for evaluation and treatment of OME, tympanic membrane perforation, or tympanic membrane retraction
-dysfunction of the ET is suspected by the ENT surgeon
-the patient is a candidate for Balloon dilation of the ET
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 65
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-previous serious allergic reaction to iodine based contrast medium
-increased risk of bleeding
-serious heart disease
-diabetes I
-previous ENT-surgery (t-tubes excluded)
-middle ear disease, which requires other type of treatment
-chronic rhino sinusitis or nasal polyposis
-anatomical variations in the temporal bone or scull base that contraindicates balloon dilation
-females who are pregnant or breast feeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To diagnose dysfunction in the eustachian tube by injecting an iodine based contrast medium into the middle ear followed by CT imaging;Secondary Objective: Safety assessments;Primary end point(s): Clinical sucsess after balloon dialtion;Timepoint(s) of evaluation of this end point: Three and six months after contrast medium injection and balloon dilation

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To visualise contrast medium in the epipharyngeal Space or if not obstruction level.<br>Clinical signs of tympanic inflammation<br>Quality of life assessment;Timepoint(s) of evaluation of this end point: 10 minutes after contrast medium injection<br>Three and six months after balloon dilation