Post-Market Clinical Follow-Up Study of the Solo+ Tympanostomy Tube Device
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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 population
Adult and paediatric patients (over 6 months) requiring tympanostomy tube placement treated with Solo+ TTD. It is anticipated at least 75% of the study population will be comprised of paediatric patients (under 18 years of age)
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Solo+ Tympanostomy Tube Device (Solo+ TTD)
Deviceinsertion of eartubes
Treatment groups
160 Participants
are divided into 1 treatment groupGroup A: adults and pedriatic patients who have had eartubes inserted, both prospective and retrospective.1 intervention
Trial outcomes
Primary outcomes
1
Procedure Success (Performance)
Percentage of subjects in which the tympanostomy tube is inserted in all indicated ears in a single procedure without the need to schedule a secondary procedure
Time frame
48 months2
Functioning Tubes (Performance)
Percentage of ears with a functioning tube (without extrusion and without occlusion) at standard of care follow-up visits until tube extrusion or discharge from standard clinical care
Time frame
48 months3
Early Adverse Event (AE) Rates (Safety)
Incidence and nature of device- or procedure-related AEs (per ear and per subject) from the day of the procedure to first follow-up visit post procedure
Time frame
48 monthsSponsors and contacts
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Source ClinicalTrials.gov