An observational study in Otitis Media and Middle Ear Infections, sponsored by AventaMed DAC. Recruiting at 1 site in Italy. Open to participants aged 6 Months and older. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by AventaMed DAC · Observational
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.
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.
284 studies on the registry are indexed under Otitis Media; 33 are open to participants now.
This study's planned enrollment of 160 is close to the median of 155 across 72 observational studies indexed under Otitis Media.
Browse Otitis Media studies →AventaMed DAC is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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)
Exclusion Criteria:
Device: Solo+ Tympanostomy Tube Device (Solo+ TTD)
insertion of eartubes
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 months
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 months
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 months
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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