Perf-Fix Study for Chronic Tympanic Membrane Repair

Tympanogen

Status: Enrolling

Conditions: Tympanic Membrane Perforation

Treatments: Device: Perf-Fix Otologic Gel Patch

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT06083181

2SB1DC018255-02 (U.S. NIH Grant/Contract)

TYMP001

1203

Details and patient eligibility

About

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.

Enrollment: 88 estimated patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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88 participants in 1 patient group

Treatment group

Experimental group

Description:

Treatment group receives one application of Perf-Fix

Treatment:

Device: Perf-Fix Otologic Gel Patch