RecruitingNCT07029997

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


Sponsor

AventaMed DAC

Enrollment

160 participants

Start Date

May 21, 2026

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 6 Months

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Solo+ Tympanostomy Tube Device (Solo+ TTD) for people with middle ear infections and otitis media. The study is currently recruiting participants at 1 location. People eligible for this study include aged 6 Months and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESolo+ Tympanostomy Tube Device (Solo+ TTD)

insertion of eartubes


Locations(1)

I.R.C.C.S. Materno Infantile Burlo Garofolo

Trieste, Trieste (TS), Italy

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NCT07029997


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