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New registry to monitor balloon procedure for Children's ear troubles

NCT ID NCT07071298

Knowledge-focused Sponsor: Integra LifeSciences Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times

Summary

This study is a registry that will follow 300 children under 18 who receive a balloon dilation treatment for Eustachian tube dysfunction. Researchers will track how often the procedure fails and needs repeat surgery. The goal is to confirm the device's real-world performance in kids.

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.

Participants

About 300 people

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

Started

Jun 2025

Expected to finish

Feb 2031

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.

Who is studied

Subjects under the age of 18 with ETD who are treated with the AERA® device

Ages

Up to 18 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: 1. Age \<18 2. Specific indications for ETBD are documented 3. ETBD with AERA device attempted- Exclusion Criteria: 1. ETBD with device other than AERA® 2. Previous ETBD procedure-

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Conditions

The condition(s) this trial relates to.

eustachian tube disorder

As listed by the trial registrant

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

Dysfunction of eustachian tube

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    9 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Boston Children's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Children's Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55404, United States

  • Cincinnati Children's Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Ear and Sinus Institute

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • Michigan Pediatric ENT Associates

    RECRUITING

    West Bloomfield, Michigan, 48322, United States

  • Stanford University

    RECRUITING

    Palo Alto, California, 94304, United States

  • Texas Children's Hospital

    RECRUITING

    Houston, Texas, 77401, United States

  • University of Utah

    RECRUITING

    Salt Lake City, Utah, 84113, United States