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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.
Age
5 - No limit years
Sex
ALL
Healthy Volunteers
No
House Institute
Los Angeles, California, United States
Advanced ENT & Allergy
Louisville, Kentucky, United States
South Louisiana Ear, Nose, and Throat
Mandeville, Louisiana, United States
Mass Eye and Ear
Boston, Massachusetts, United States
Carolina Ear & Hearing Clinic
Raleigh, North Carolina, United States
Eastern Virginia Medical School
Norfolk, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Start Date
April 4, 2024
Primary Completion Date
February 1, 2026
Completion Date
March 1, 2026
Last Updated
January 16, 2026
88
ESTIMATED participants
Perf-Fix Otologic Gel Patch
DEVICE
Lead Sponsor
Tympanogen
Collaborators
NCT02918942
NCT03837665
NCT02019888
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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