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Gel patch mends eardrums without surgery – new study shows promise

NCT ID NCT06083181

Disease control Sponsor: Tympanogen 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested a gel patch called Perf-Fix that doctors place over a chronic hole in the eardrum to help it close naturally. 71 people aged 5 and older with large, non-healing eardrum holes took part. The main goals were to see if the patch safely closes the hole and how easy it is for doctors to apply.

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

71 people

The number who actually took part.

Started

Apr 2024

Finished

Jan 2026

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

5 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: * Willing and able to provide informed consent, legally authorized representative (LAR) consent, or LAR consent and assent when age appropriate * Females and males at least 5 years old * Perforation involves \>25% of the tympanic membrane * Perforation has not spontaneously closed after 4 weeks of watchful waiting * Perforation is not actively healing * Perforation can be visualized by an endoscope or microscope * Ear wax does not occlude the perforation Exclusion Criteria: * Perforation is marginal (a perforation that has an area with no tympanic membrane between the perforation and the bony canal) * Active otitis media, with or without effusion * Otorrhea from the middle ear for more than 3 months * History of cleft palate * Receiving radiation therapy or taking corticosteroids, immunosuppressive agents, or chemotherapy * Currently taking systemic antibiotics, antibiotic ear drops, and/or steroid ear drops * Current bacterial or viral infection * Fever (Temperature \>100°F) at time of index procedure * Diagnosed with cholesteatoma mass in the tympanic cavity * Known history of malignant ear canal tumors within 3 years of screening for eligibility * Abrasions/lacerations to the external auditory canal * Significant medical condition that could prevent full participation in the procedures required for the study * Investigator feels the subject will be unable to cooperate with the application procedure * Parent/LAR feels the subject will be unable to cooperate with the application procedure * Allergy to shellfish * Known to be or could be pregnant * Adults lacking capacity to consent

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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.

Tympanic membrane perforation

Contacts and locations

Locations

  • Advanced ENT & Allergy

    Louisville, Kentucky, 40220, United States

  • Carolina Ear & Hearing Clinic

    Raleigh, North Carolina, 27609, United States

  • Eastern Virginia Medical School

    Norfolk, Virginia, 23507, United States

  • House Institute

    Los Angeles, California, 90017, United States

  • Mass Eye and Ear

    Boston, Massachusetts, 02114, United States

  • South Louisiana Ear, Nose, and Throat

    Mandeville, Louisiana, 70471, United States

  • Virginia Commonwealth University

    Richmond, Virginia, 23219, United States

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