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Ear drum holes repaired in minutes with growth factor gel

NCT ID NCT06448039

Disease control Sponsor: D. Bradley Welling, MD, PhD 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a gel containing fibroblast growth factor 2 (FGF2) can close long-lasting holes in the ear drum. Twenty adults with dry ear drum holes that have persisted for over six months will receive either the FGF2 gel or a saltwater placebo. The gel is applied in the doctor's office, and up to four treatments may be given. The goal is to see if this simple approach can heal the hole and improve hearing.

What this could mean

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

Active substance
Fibroblast Growth Factor 2 (FGF2)
What this could lead to
If it works, this could provide a simple, in-office treatment to close chronic ear drum holes without surgery.
What could go wrong
This is a small early-phase trial with only 20 participants. The treatment may not work better than placebo, and up to four applications are needed.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 20 people

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

Started

Jun 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 years and older

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. 18 years of age and older. 2. Confirmed tympanic membrane perforation for more 6 months or longer. 3. Confirmed dry perforation. 4. Confirmed central perforation. 5. Ability to provide informed consent. Exclusion Criteria: 1. Patient is receiving or has a prior history of radiation treatment. 2. Prior tympanoplasty with failure. 3. Currently use of corticosteroids, immunosuppressive agents, or chemotherapy. 4. Active middle ear infection or inflammation on otoscopic examination

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As listed by the trial registrant

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

Chronic tympanic membrane perforation

Contacts and locations

Locations

  • Massachusetts Eye and Ear

    Boston, Massachusetts, 02214, United States