Perf-Fix Study for Chronic Tympanic Membrane Repair (NCT06083181) | Clinical Trial Compass
CompletedNot Applicable
Perf-Fix Study for Chronic Tympanic Membrane Repair
United States71 participantsStarted 2024-04-05
Plain-language 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.
Who can participate
Age range
5 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 coo…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.