Breakthrough ear tube device could make surgery obsolete for kids

NCT ID NCT05741333

Ongoing Disease control Sponsor: AventaMed DAC Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new device called Solo+ that places tiny tubes in the eardrums of children with ear infections. The goal is to see if it is safe and effective when done in a doctor's office instead of an operating room. About 66 children aged 6 months to 12 years will be enrolled. The device aims to simplify treatment and reduce the need for general anesthesia.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Solo+ Tympanostomy Tube Device
What this could lead to: If successful, this device could offer a simpler, in-office way to place ear tubes in children, reducing the need for general anesthesia.
What could go wrong: This is a small, early-stage study with only 66 participants, so results may not apply to all children. Risks include device-related complications like infection or tube blockage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

ear infection otitis media

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

EAR INFECTION OTITIS MEDIA

Contacts and locations

Locations

Advanced ENT & Allergy

Louisville, Kentucky, 40220, United States
East Alabama ENT

Opelika, Alabama, 36801, United States
North Alabama ENT

Huntsville, Alabama, 35801, United States
Sacramento ENT

Sacramento, California, 95661, United States
South Carolina ENT

Columbia, South Carolina, 29203, United States
Southern Head & Neck Surgery

Alexander City, Alabama, 35010, United States
Specialty Physician Associates

Bethlehem, Pennsylvania, 18017, United States

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