Active — Not RecruitingNot Applicable

In-Office Clinical Study of the Solo+ TTD

United States66 participantsStarted 2023-03-30

Plain-language summary

The objective of this study is to evaluate the safety and effectiveness of the Solo+ Tympanostomy Tube Device (Solo+ TTD) for the placement of tympanostomy tubes in paediatric patients undergoing a tympanostomy procedure.

Who can participate

Age range

6 Months – 13 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: * Patients aged ≥6 months to \<13 years * Planned tympanostomy tube insertion * Patient is able to commit to the follow-up visits and assessments Exclusion Criteria: * Anatomy that precludes sufficient visualization of the tympanic membrane * Anatomy that precludes safe access to the tympanic membrane and safe use of the Solo+ TTD * Narrow ear canals * Congenital or craniofacial abnormalities affecting the ear * No baseline audiometry or tympanometry * Familial history of insensitivity to anesthetic components * Patient unable to remain still or is unsuitable for protective stabilization to undergo an in-office procedure

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

Procedure Success

Timeframe: Intra-operative

Rate of Adverse Events

Timeframe: 24 months

Trial details

NCT IDNCT05741333

SponsorAventaMed DAC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05

View on ClinicalTrials.gov More Ear Infection trials

Who can participate

Age range

6 Months – 13 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.