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Could a gel patch fix a hole in your ear drum?

NCT ID NCT04960384

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 2 trial tested whether a gel containing fibroblast growth factor-2 (FGF-2) can close long-standing holes in the ear drum. 52 adults with dry ear drum perforations lasting at least 6 months were randomly assigned to receive either the FGF-2 gel or a placebo, applied up to three times. The main goal was to see if the hole closed, measured by ear exams and photos.

What this could mean

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

Active substance
FGF-2 (fibroblast growth factor-2) applied on a gelatin sponge with fibrin glue
What this could lead to
If it works, this could provide a simple, non-surgical way to close chronic ear drum holes, potentially improving hearing and reducing infection risk.
What could go wrong
This is a small phase 2 trial with only 52 participants, so results may not apply to everyone. The treatment may not close the hole, and risks like infection or incomplete healing are possible.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

52 people

The number who actually took part.

Started

May 2022

Finished

Oct 2025

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: * Age 18 years and older * Dry tympanic membrane perforation of at least 6 months duration * Any person of child-bearing potential, must have a negative beta-HCG test and must agree to use an adequate form of birth control throughout the clinical trial. Exclusion Criteria: * Active otitis media or chronic otorrhea from the middle ear * Subjects receiving radiation therapy, corticosteroids, immunosuppressive agents, or chemotherapy * Subjects who, at study entry, are taking systemic antibiotics * Subjects who are immunosuppressed * Subjects experiencing bacterial or viral infection or who may otherwise be febrile or may be with inflammation. * Life expectancy of less than 1 year * Active alcohol or drug abuse within 6 months prior to study entry * Significant medical condition that could prevent full participation in the procedures required for the study * Known or suspected allergies to any components used in the study, i.e. porcine collagen * Subjects who have cholesteatoma mass, or endothelium invasion in the tympanic cavity * Subjects whose total perforation cannot be seen by an endoscope * Subjects with inadequately controlled diabetes mellitus (NGSP: HbA1c 6.9% or higher) * Subjects with a history of malignant ear canal tumors within 3 years of screening for eligibility * Subjects who have undergone prior myringoplasty or tympanoplasty * Subjects whose TMP is a result of thermal burn, or radiation therapy. * Subjects who have abnormalities in the auditory ossicles or their linkages * Subjects having moderate to severe dementia such as Alzheimer's disease or senile dementia * Subjects whose hearing ability does not improve to bone-conduction hearing on a hearing acuity test using the tentative closure of perforation with a wet cotton ball. * Subject having residual TM with abnormal form or abnormal shape anatomically * Subjects having any granulation or soft tissue density due to inflammation, or infection in mastoid antrum determined by CT scanning (Temporal bone CT scanning)

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Conditions

The condition(s) this trial relates to.

Tympanic Membrane Perforation

As listed by the trial registrant

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

Contacts and locations

Locations

  • NYU Langone Health

    New York, New York, 10016, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.