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Post-Market Clinical Follow-Up Study of the Solo+ Tympanostomy Tube Device
Sponsor: AventaMed DAC
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.
Key Details
Gender
All
Age Range
6 Months - Any
Study Type
OBSERVATIONAL
Enrollment
160
Start Date
2025-07
Completion Date
2029-07
Last Updated
2025-06-19
Healthy Volunteers
No
Conditions
Interventions
Solo+ Tympanostomy Tube Device (Solo+ TTD)
insertion of eartubes