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

AventaMed

Status: Not yet enrolling

Conditions: Otitis Media; Middle Ear Infections

Treatments: Device: Solo+ Tympanostomy Tube Device (Solo+ TTD)

Study type: Observational

Funder types: Industry

Identifiers

NCT07029997

CSP004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 6+ months old

Volunteers: No Healthy Volunteers

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

Trial design

160 participants in 1 patient group

adults and pedriatic patients who have had eartubes inserted, both prospective and retrospective.

Treatment:

Device: Solo+ Tympanostomy Tube Device (Solo+ TTD)