Post-Market Clinical Follow-Up Study of the Solo+ Tympanostomy Tube Device
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6+
SponsorAventaMed DAC
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
None
Trial design
Treatments tested in this trial
- Solo+ Tympanostomy Tube Device (Solo+ TTD)
Treatment groups
160 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov