Status:
RECRUITING
Perf-Fix Study for Chronic Tympanic Membrane Repair
Lead Sponsor:
Tympanogen
Collaborating Sponsors:
National Institute on Deafness and Other Communication Disorders (NIDCD)
NAMSA
Conditions:
Tympanic Membrane Perforation
Eligibility:
All Genders
5+ years
Phase:
NA
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT06083181
Start Date
April 4 2024
End Date
December 1 2025
Last Update
July 11 2025
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
House Institute
Los Angeles, California, United States, 90017
2
Advanced ENT & Allergy
Louisville, Kentucky, United States, 40220
3
South Louisiana Ear, Nose, and Throat
Mandeville, Louisiana, United States, 70471
4
Mass Eye and Ear
Boston, Massachusetts, United States, 02114