Perf-Fix Study for Chronic Tympanic Membrane Repair

Launched by TYMPANOGEN · Oct 12, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Perf-Fix, which is a gel patch designed to help heal long-lasting holes (perforations) in the eardrum that cover more than 25% of its surface. These holes have not healed on their own after at least four weeks. The goal is to see if applying this gel patch can support the natural healing process and close these persistent eardrum perforations.

People who might be eligible to join are males and females at least 5 years old who have a large, non-healing hole in their eardrum that can be seen with special instruments like a microscope. To participate, the hole must not be near the edge of the eardrum, and there should be no active ear infection or other serious ear conditions. Participants should be able to cooperate with the treatment and give consent themselves or have a legal guardian provide consent if needed. During the study, participants will have the gel patch applied to their eardrum, and the researchers will monitor how well it helps the hole heal. It’s important to know that people with certain health conditions, allergies to shellfish, or who are pregnant cannot join this study. This trial is currently looking for volunteers who meet these criteria.

Gender

ALL

Eligibility criteria

• Inclusion 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
• Exclusion Criteria:
• • 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