In-Office Tympanostomy Tube Placement in Children (OTTER) (NCT03323736) | Clinical Trial Compass
CompletedPhase 3
In-Office Tympanostomy Tube Placement in Children (OTTER)
United States, Canada370 participantsStarted 2017-10-31
Plain-language summary
A prospective, single-arm, multicenter study to evaluate effectiveness and safety of Tymbion iontophoresis and tympanostomy tube placement using the Tula Iontophoresis and Tube Delivery Systems for children in an office setting.
Who can participate
Age range
6 Months – 12 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
. Males or females at least 6 months old through 12 years old at time of consent
. Indication for tympanostomy tube insertion per Clinical Practice Guideline
. Behavioral capacity and cooperative temperament to undergo an awake procedure, based on physician judgment (not applicable to OR Lead-In subjects)
. Subject's parent/guardian and subject are able and willing to comply with the protocol and attend all study visits
. Subject's parent/guardian and subject are able and willing to provide informed consent or assent as age appropriate
Exclusion criteria
. Significantly atrophic, retracted, bimeric, monomeric or atelectatic tympanic membrane
. Perforated tympanic membrane
. Otitis externa
. Active or recent conditions of the tympanic membrane (eg, prior myringotomy with incomplete wound healing or re-epithelization)
. Hemotympanum
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
Procedural Success:
Timeframe: Day of Procedure (Day 0) Immediately following tube placement
2
Tube Placement Tolerability
Timeframe: Day of Procedure (Day 0) Immediately following tube placement
. Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane potentially causing abrasion or irritation to the external ear canal
. Anatomy that precludes sufficient visualization of and access to the tympanic membrane