Balloon Dilation of the Eustachian Tube in Children (NCT03499015) | Clinical Trial Compass
UnknownNot Applicable
Balloon Dilation of the Eustachian Tube in Children
Austria50 participantsStarted 2018-12-14
Plain-language summary
Otitis media with effusion (OME) is very common in children and characterized by fluid in the middle ear without signs or symptoms of acute ear infection. Treatment options are tympanostomy tubes and/or adenoidectomy. However OME often reoccurs after these procedures.
Goal of this study will be to evaluate the Balloon Eustachian Tuboplasty (BET) in children as an additional treatment option and to assess long-term effects of BET. Beside the standard procedure, children (4 to 10 years of age), with equal pathology on both ears, will be assigned for BET on side.
Who can participate
Age range
4 Years – 10 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:
* OME on both sides measured by flat tympanometry
Exclusion Criteria:
* Patients with cleft lip and/or palate and other severe craniofacial abnormalities
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
Tympanometry-Change (Middle ear effusion/eardrum mobility assessed with Tympanometry)
Timeframe: up to 3 months preoperatively and change to 3, 6 and 9 months postoperatively;