CompletedNot Applicable

Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter

United States323 participantsStarted 2014-02-01

Plain-language summary

The objective of this study is to determine whether Eustachian tube dilation in conjunction with medical management or medical management alone is effective for treating Eustachian tube dysfunction.

Who can participate

Age range

22 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: * Adult male or female aged 22 years and older * Persistent Eustachian tube dysfunction * Failure of medical management * Positive diagnosis of ETD * Absence of internal carotid artery (ICA) dehiscence * Able to read and understand English Exclusion Criteria: * Females who are pregnant or lactating * Anatomy that requires an adjunctive surgical procedure * Concomitant nasal or sinus procedures planned on the same day as surgical procedure * Concomitant ear procedures planned on the same day as surgical procedure * History of major surgery of the head or neck within four (4) months prior to surgery * History of patulous ET * History of fluctuating sensorineural hearing loss * Active acute otitis media * Tympanic membrane perforation * Tympanosclerosis * Acute upper respiratory infection * Temporomandibular joint disorder * Cleft palate * Craniofacial syndrome * Cystic fibrosis * Ciliary dysmotility syndrome * Systemic mucosal or immunodeficiency disease * Intolerance of medication for ETD * Prior intervention of Eustachian tube

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

Primary Efficacy Analysis: Number of Randomized Subjects With Tympanogram Normalization at 6 Weeks

Timeframe: 6 Week Follow-Up Visit

Trial details

NCT IDNCT02087150

SponsorIntegra LifeSciences Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-12-01

Results submitted2018-07-27

View on ClinicalTrials.gov More Eustachian Tube Dysfunction trials

Who can participate

Age range

22 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.