Perf-Fix Study for Chronic Tympanic Membrane Repair

April 13, 2026 updated by: Tympanogen

A Multicenter, Prospective, Open-label Clinical Trial to Evaluate the Safety and Effectiveness of the Perf-Fix Otologic Gel Patch to Aid in the Repair of Chronic Tympanic Membrane Perforation

The purpose of the study is to assess the effectiveness of Perf-Fix as a gel patch to aid in the natural healing process to close chronic, >25% tympanic membrane perforation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
71

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90017
        • House Institute
    • Kentucky
      • Louisville, Kentucky, United States, 40220
        • Advanced ENT & Allergy
    • Louisiana
      • Mandeville, Louisiana, United States, 70471
        • South Louisiana Ear, Nose, and Throat
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Mass Eye and Ear
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • Carolina Ear & Hearing Clinic
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Eastern Virginia Medical School
      • Richmond, Virginia, United States, 23219
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment group
Treatment group receives one application of Perf-Fix
Device: Perf-Fix Otologic Gel Patch
Gel patch application
Other Names:
  • Perf-Fix

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Eardrum closure
Time Frame: 12 weeks
The rate of success in Perf-Fix closing perforated eardrums. Success is defined as closure of the perforation.
12 weeks
Device- and procedure-related safety
Time Frame: 12 weeks
Incidence of adverse events over the course of the study for each subject.
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Procedural success
Time Frame: 1 hour

Perf-Fix is successfully applied by the clinician to the subject's eardrum perforation, measured as Yes/No.

Procedural Success (ALL steps accomplished):

  • complete device preparation
  • apply device to tympanic membrane perforation
  • complete curing process using light guide and curing light
  • visualize cured device on tympanic membrane perforation
  • subject recovers from procedure

Procedural Failure (including but not limited to):

  • inability to apply device to tympanic membrane perforation
  • device does not adhere to tympanic membrane
  • behavioral intolerance to procedure
  • all steps for Procedural Success not completed
1 hour
Perforation size - percent area
Time Frame: 1 hour
Size of perforation measured in percent area of eardrum.
1 hour
Perforation size - length and width
Time Frame: 1 hour
Size of perforation measured in mm across length and width of perforation.
1 hour
Perforation location
Time Frame: 12 weeks
Quadrant(s) of perforation location: Anterosuperior, anteroinferior, posterosuperio, and/or posteroinferior
12 weeks
Time of procedure
Time Frame: 1 hour
Time taken to apply Perf-Fix in single application
1 hour
Time to heal
Time Frame: 12 weeks
Time from Perf-Fix application to tympanic membrane healing
12 weeks
Air-bone gap
Time Frame: 12 weeks
Measurement of air-bone gap by audiogram at 500, 1000, and 2000 Hz
12 weeks
Word recognition
Time Frame: 12 weeks
Measurement of hearing ability by percent of words correctly recognized
12 weeks
Tympanometry
Time Frame: 12 weeks
Measurement of tympanic membrane integrity as normal or abnormal
12 weeks
Procedure tolerability
Time Frame: 1 hour
Assess pain/discomfort using Visual Analogue Scale before and after each Perf-Fix application procedure on a scale 0-10 (0=no pain, 10=unbearable pain)
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tympanogen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Deafness and Other Communication Disorders (NIDCD)
NAMSA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 5, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 13, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TYMP001
  • 1203 (Other Grant/Funding Number: VA Catalyst)
  • 2SB1DC018255-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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