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

Not yet recruiting

• Conditions: Otitis Media; Middle Ear Infections

• Registration Number: NCT07029997
• Lead Sponsor: AventaMed DAC

Brief 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.

Detailed Description

Patients are being asked to participate in this study because they have been treated, will be treated, or have undergone a treatment attempt with the Solo+ Tympanostomy Tube Device (Solo+ TTD), manufactured by AventaMed. The Solo+ TTD device is a CE marked device designed to deploy ear tubes across the ear drum.

Ear tubes (also known as tympanostomy tubes or ventilation tubes) are predominantly used in treating repeated or long-term middle ear infections, or to treat a build-up of fluid in the middle ear, mostly in children, yet also used for adults. Ear tube insertion allows for air to ventilate the middle ear space and drain fluid from the middle ear.

The Solo+ Tympanostomy Tube Device (Solo+ TTD) is an all-in-one device for the insertion of ear tubes using as little as topical anaesthesia, without requiring general anaesthesia as is the case for other similar devices. The Solo+ TTD is approved for use in children and adults. It is available in Europe and already in use by some clinics and hospitals.

The purpose of this study is to collect information about the use the Solo+ TTD.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-12
• Study First Submitted QC: 2025-06-12
• Last Update Submitted: 2025-06-12
• Study First Posted: 2025-06-19
• Last Update Posted: 2025-06-19
• Study Start: 2025-07
• Primary Completion: 2029-07
• Study Completion: 2029-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• 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.

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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