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

Condition(s) studied

Investigational drug(s) / intervention(s)

Solo+ Tympanostomy Tube Device (Solo+ TTD): insertion of eartubes

Study 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

Primary outcome measure(s)

• Procedure Success (Performance) — 48 months
  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
• Functioning Tubes (Performance) — 48 months
  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
• Early Adverse Event (AE) Rates (Safety) — 48 months
  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

Trial sites (1)