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Perf-Fix Study for Chronic Tympanic Membrane Repair
Sponsor: Tympanogen
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
5 Years - Any
Study Type
INTERVENTIONAL
Enrollment
88
Start Date
2024-04-04
Completion Date
2026-03
Last Updated
2026-01-16
Healthy Volunteers
No
Conditions
Interventions
Perf-Fix Otologic Gel Patch
Gel patch application
Locations (7)
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