Not Yet RecruitingNot Applicable

Post-Market Clinical Follow-Up Study of the Solo+ Tympanostomy Tube Device

160 participantsStarted 2025-07

Plain-language summary

The purpose of this project is to collect information from the doctor notes about the use of the device, to monitor the tubes after surgery, and collect information from patients and parents/guardians about their views on the procedure. Since the device became available in Europe, it is important to collect information from both patients planned for the procedure (prospective) and those who already underwent the procedure (retrospective) to have collect as much data as possible.

Who can participate

Age range6 Months

SexALL

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: * Subject and/or Parent/Guardian is able to understand the information document and (depending in the country's legislation) does not object participating or is willing to provide documented informed consent * Subject was or will be treated, or had a treatment attempted with the study device. Exclusion Criteria: * None

What they're measuring

Procedure Success (Performance)

Timeframe: 48 months

Functioning Tubes (Performance)

Timeframe: 48 months

Early Adverse Event (AE) Rates (Safety)

Timeframe: 48 months

Trial details

NCT IDNCT07029997

SponsorAventaMed DAC

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2029-07

View on ClinicalTrials.gov More Otitis Media trials