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Breakthrough ear tube device could make surgery obsolete for kids

NCT ID NCT05741333

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 66 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2023

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 months to 13 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients aged ≥6 months to \<13 years * Planned tympanostomy tube insertion * Patient is able to commit to the follow-up visits and assessments Exclusion Criteria: * Anatomy that precludes sufficient visualization of the tympanic membrane * Anatomy that precludes safe access to the tympanic membrane and safe use of the Solo+ TTD * Narrow ear canals * Congenital or craniofacial abnormalities affecting the ear * No baseline audiometry or tympanometry * Familial history of insensitivity to anesthetic components * Patient unable to remain still or is unsuitable for protective stabilization to undergo an in-office procedure

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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

More trials for these conditions

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