RECRUITING

Perf-Fix Study for Chronic Tympanic Membrane Repair

Description

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.

Conditions

Tympanic Membrane Perforation
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Related Conditions:

Tympanic Membrane Perforation

Study Overview

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Study Details

Study overview

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.

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

Perf-Fix Study for Chronic Tympanic Membrane Repair

Condition
Tympanic Membrane Perforation
Intervention / Treatment

-

Contacts and Locations

Los Angeles

House Institute, Los Angeles, California, United States, 90017

Louisville

Advanced ENT & Allergy, Louisville, Kentucky, United States, 40220

Mandeville

South Louisiana Ear, Nose, and Throat, Mandeville, Louisiana, United States, 70471

Boston

Mass Eye and Ear, Boston, Massachusetts, United States, 02114

Raleigh

Carolina Ear & Hearing Clinic, Raleigh, North Carolina, United States, 27609

Norfolk

Eastern Virginia Medical School, Norfolk, Virginia, United States, 23507

Richmond

Virginia Commonwealth University, Richmond, Virginia, United States, 23219

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

5 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Tympanogen,

Study Record Dates

2025-12