Perf-Fix Study for Chronic Tympanic Membrane Repair

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.

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