CompletedPhase 2/3

Evaluation of the Tympanostomy Tube Delivery System

United States53 participantsStarted 2010-09

Plain-language summary

The purpose of this study is to evaluate the performance and safety of the Tympanostomy Tube Delivery System (TTDS) for chronic otitis media or recurrent acute otitis media.

Who can participate

Age range

6 Months

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: * Diagnosed with either chronic otitis media with effusion or acute otitis media and scheduled to undergo tympanostomy tube insertion Exclusion Criteria: * Reaction to anesthesia * Markedly atrophic, bimeric, severely retracted, atelectatic or perforated tympanic membrane * Otitis externa * Active acute otitis media * Otitis media pathology requiring T-tubes * Stenosed ear canal * Anatomy that precludes visualization and access to tympanic membrane * Anatomy that necessitates tympanostomy tube placement in posterior half of membrane

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

Safety of Tympanostomy Tube (TT) Delivery System

Timeframe: 7 days

Device Success

Timeframe: 0 days

Trial details

NCT IDNCT01202578

SponsorIntegra LifeSciences Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-11

Results submitted2014-05-07

View on ClinicalTrials.gov More Otitis Media With Effusion trials

Who can participate

Age range

6 Months

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.