Perf-Fix Study for Chronic Tympanic Membrane Repair

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: Completed
• Conditions: Tympanic Membrane Perforation
• Intervention / Treatment: Device: Perf-Fix Otologic Gel Patch

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Eardrum closure	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	Incidence of adverse events over the course of the study for each subject.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural success	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	Size of perforation measured in percent area of eardrum.	1 hour
Perforation size - length and width	Size of perforation measured in mm across length and width of perforation.	1 hour
Perforation location	Quadrant(s) of perforation location: Anterosuperior, anteroinferior, posterosuperio, and/or posteroinferior	12 weeks
Time of procedure	Time taken to apply Perf-Fix in single application	1 hour
Time to heal	Time from Perf-Fix application to tympanic membrane healing	12 weeks
Air-bone gap	Measurement of air-bone gap by audiogram at 500, 1000, and 2000 Hz	12 weeks
Word recognition	Measurement of hearing ability by percent of words correctly recognized	12 weeks
Tympanometry	Measurement of tympanic membrane integrity as normal or abnormal	12 weeks
Procedure tolerability	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

• Sponsor: Tympanogen
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD); NAMSA

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2024
• Primary Completion (Actual): January 30, 2026
• Study Completion (Actual): January 30, 2026

Study Registration Dates

• First Submitted: September 11, 2023
• First Submitted That Met QC Criteria: October 12, 2023
• First Posted (Actual): October 13, 2023

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: pediatric; tympanoplasty; myringoplasty; tympanic membrane; eardrum
• Additional Relevant MeSH Terms: Wounds and Injuries; Otorhinolaryngologic Diseases; Ear Diseases; Tympanic Membrane Perforation
• Other Study ID 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