Long-term Assessment of Balloon Eustachian Tuboplasty for Obstructive Eustachian Tube Disease (NCT05998356) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Long-term Assessment of Balloon Eustachian Tuboplasty for Obstructive Eustachian Tube Disease
96 participantsStarted 2023-10-01
Plain-language summary
To date, more than 130 000 Balloon Eustachian Tuboplasty (BET) procedures have been performed worldwide. This procedure is proposed in case of Obstructive Eustachian Tube Dysfunction (OETD) with or without chronic otitis media. However, the effectiveness of this procedure is still discussed amongst otolaryngologist. Most of studies,were open label prospective studies comparing Eustachian tube function before and after surgical treatment. A recent meta-analysis suggests that BET procedure improves postoperative Eustachian tube function, but high-level evidence is still lacking. In this project, the investigators propose to perform the first blinded randomized controlled trial procedure to assess the changes of Eustachian tube function after BET in a population of subjects with chronic OETD with or without chronic otitis. Prognosis factors of efficacy will be also investigated during the study.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged between 18 and 85 years
* Clinical symptoms of OETD with Eustachian tubal score less or equal to 7/14
* Failure of well conducted medical treatment (GERD, allergy, rhinosinusitis) including pressure equalization device used for 1 month or more
* ASA score 1 or 2 (ASA : American Society of Anesthesiologists)
Exclusion Criteria:
* Palatal cleft
* Anatomical anomaly of pharyngeal Eustachian tube ostium on the treated side
* Medical history of nasopharyngeal radiotherapy
* Medical history of middle ear surgery (except myringotomy and/or tympanostomy tube)
* Eardrum perforation in the treated side
* Contraindication of general anesthesia, or major risk of general anesthesia including ASA scores of 3 and 4
* Major nasal obstruction ipsilateral to the Eustachian tube to treat
* Medical history of previous Eustachian Tube Dilation
* Pregnant or nursing woman, or in childbearing age and not willing to use contraception
* Inclusion in another interventional clinical trial
* Protected and vulnerable adult
* Not covered by Health insurance
* Refusal to sign informed consent form
* Subjects unable to attend all scheduled visits or to comply with all trial procedures
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Eustachian Tubal Score (ETS)
Timeframe: ETS is calculated at the inclusion, between 2 and 5 months after the inclusion, and between 6 and 9 months after the inclusion