CompletedNot Applicable

Tympanostomy Tube Placement in Children in the Office (Inova Study)

United States70 participantsStarted 2011-12

Plain-language summary

The objective of the study is to evaluate the safety and efficacy of the Acclarent Tula TDS for the placement of tympanostomy tubes under local anesthesia in an office/clinic setting.

Who can participate

Age range

6 Months – 21 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

. Scheduled to undergo tympanostomy tube insertion
. At least 6 months old and younger than 22 years old
. Behavioral capacity and cooperative temperament to undergo an awake procedure (based on physician judgement)
. No history of sensitivity or reaction to anesthesia chosen for the procedure

Exclusion criteria

. Pregnant or lactating females
. Significantly atrophic, bimeric, or completely atelectatic tympanic membrane
. Otitis externa
. Lacerations or abrasions to the external auditory canal or damaged or denuded skin in the auditory canal
. Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane
. Electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.)
. Anatomy that precludes sufficient visualization of and access to the tympanic 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

Number of Participants With Procedural, Serious, and Device-Related Adverse Events

Timeframe: procedure up to 2 weeks post procedure

Device Success

Timeframe: Day 0 (day of procedure)

Trial details

NCT IDNCT01496287

SponsorIntegra LifeSciences Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-04

Results submitted2014-06-26

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