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ACTIVE NOT RECRUITING
NCT06083181
NA

Perf-Fix Study for Chronic Tympanic Membrane Repair

Sponsor: Tympanogen

View on ClinicalTrials.gov

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

Interventions

DEVICE

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