NCT06083181CompletedNot Applicable
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
Tympanogen7 sites in 1 country71 target enrollmentStarted: April 5, 2024Last updated:
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 71
- Locations
- 7
- Primary Endpoint
- Eardrum closure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 5 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Treatment group
Experimental
Treatment group receives one application of Perf-Fix
Intervention: Perf-Fix Otologic Gel Patch (Device)
Outcomes
Primary Outcomes
Eardrum closure
Time Frame: 12 weeks
The rate of success in Perf-Fix closing perforated eardrums. Success is defined as closure of the perforation.
Device- and procedure-related safety
Time Frame: 12 weeks
Incidence of adverse events over the course of the study for each subject.
Secondary Outcomes
- Time to heal(12 weeks)
- Word recognition(12 weeks)
- Tympanometry(12 weeks)
- Procedural success(1 hour)
- Perforation size - percent area(1 hour)
- Perforation size - length and width(1 hour)
- Perforation location(12 weeks)
- Time of procedure(1 hour)
- Air-bone gap(12 weeks)
- Procedure tolerability(1 hour)
Investigators
Study Sites (7)
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