Solo+ Tympanostomy Tube Device: Post-Market Follow-Up

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational post-market follow-up of the Solo+ Tympanostomy Tube Device, collecting real-world data from centers that have used the device in Europe. It includes prospective and retrospective information from patients and guardians regarding the procedure, outcomes, and satisfaction, as well as clinician notes about device use and tube status after surgery. Data are gathered without random assignment and reflect routine clinical practice. The study aims to understand safety, performance, and user experience in both current and past recipients. The study is sponsored by AventaMed DAC and conducted at a single site in Trieste, Italy.

Why it matters

Who can join: the full rules

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

Where it's running

• I.R.C.C.S. Materno Infantile Burlo Garofolo
  Trieste, Trieste (TS), Italy Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.