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

Launched by AVENTAMED DAC · Jun 12, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at the use of a small medical device called the Solo+ Tympanostomy Tube, which is used to help children and adults who have middle ear infections, also known as otitis media. The study aims to gather information from doctors’ notes and talk to patients and their families about their experiences with the device. This helps researchers understand how well the tubes work and how patients feel about the procedure, whether they are planning to have it done or have already had it.

People of all genders who have had or will have the tube placed may be eligible to join, as long as they or their parent/guardian can understand the study information and agree to participate. If you take part, doctors will monitor how the tubes are doing after surgery, and you or your family may be asked to share your thoughts about the treatment. This study is not yet recruiting participants but is important because it collects real-world information to help improve care for those with ear infections.

Gender

ALL

Eligibility criteria

• 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