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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Otitis Media Ear Diseases Middle Ear Infections Otitis Otorhinolaryngologic Diseases

Age range

6 month and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Solo+ Tympanostomy Tube Device (Solo+ TTD)

Device

insertion of eartubes

Primary outcomes

Procedure Success (Performance)

Time frame: 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)

Time frame: 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)

Time frame: 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

Sponsors and collaborators

Lead sponsor

AventaMed DAC

Industry

Registry information

Important dates

Study start: 2025
Primary completion: 2029
Study completion: 2029
First posted: Jun 19, 2025
Registry last updated: Jun 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting