Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
88 participants
INTERVENTIONAL
2024-04-04
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment group
Treatment group receives one application of Perf-Fix
Perf-Fix Otologic Gel Patch
Gel patch application
Interventions
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Perf-Fix Otologic Gel Patch
Gel patch application
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
5 Years
ALL
No
Sponsors
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National Institute on Deafness and Other Communication Disorders (NIDCD)
NIH
NAMSA
OTHER
Tympanogen
INDUSTRY
Responsible Party
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Locations
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House Institute
Los Angeles, California, United States
Advanced ENT & Allergy
Louisville, Kentucky, United States
South Louisiana Ear, Nose, and Throat
Mandeville, Louisiana, United States
Mass Eye and Ear
Boston, Massachusetts, United States
Carolina Ear & Hearing Clinic
Raleigh, North Carolina, United States
Eastern Virginia Medical School
Norfolk, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Countries
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Other Identifiers
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1203
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
TYMP001
Identifier Type: -
Identifier Source: org_study_id
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