Myringotomy Clinical Trials

Clinical trials related to Myringotomy Procedure

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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 6 months
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
I.R.C.C.S. Materno Infantile Burlo Garofolo
RECRUITING
Trieste
Time Frame
Start Date: 2026-05-21
Estimated Completion Date: 2030-05
Participants
Target number of participants: 160
Treatments
adults and pedriatic patients who have had eartubes inserted, both prospective and retrospective.
Related Therapeutic Areas
Sponsors
Leads: AventaMed DAC

This content was sourced from clinicaltrials.gov