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NCT06083181 · ClinicalTrials.gov registry record · NA
Perf-Fix Study for Chronic Tympanic Membrane Repair
A NA study of Tympanic Membrane Perforation, sponsored by Tympanogen.
- Active
- Registry status
- NA
- Development phase
- 88
- Enrollment target
- 7
- Study locations
NCT06083181: Active NA study of Tympanic Membrane Perforation, sponsored by Tympanogen.
NCT06083181 is a NA study of Tympanic Membrane Perforation that is active but no longer recruiting, run by Tympanogen. The registered enrollment target is 88 participants, below the 141-participant average among 3 other Tympanic Membrane Perforation trials with a reported enrollment target (38% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06083181, a NA study of Tympanic Membrane Perforation, is active but no longer recruiting, sponsored by Tympanogen.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 88 participants
- Enrollment target
- 7
- Study locations
Study 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.
Primary Outcome
The rate of success in Perf-Fix closing perforated eardrums. Success is defined as closure of the perforation.
Conditions Studied
Interventions
- DEVICE Perf-Fix Otologic Gel Patch
Study Locations (7)
Virginia
- Eastern Virginia Medical School - Norfolk
- Virginia Commonwealth University - Richmond
California
- House Institute - Los Angeles
Kentucky
- Advanced ENT & Allergy - Louisville
Louisiana
- South Louisiana Ear, Nose, and Throat - Mandeville
Massachusetts
- Mass Eye and Ear - Boston
North Carolina
- Carolina Ear & Hearing Clinic - Raleigh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2024-04-04 |
| Est. Completion | 2026-03 |
| Phase | NA |
What the registry record for NCT06083181 still lists
NCT06083181 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 141-participant average among 3 other Tympanic Membrane Perforation trials with a reported enrollment target (38% lower).
The record links to 1 condition, with Tympanic Membrane Perforation appearing as the primary indexed condition, and to 1 intervention - of which Perf-Fix Otologic Gel Patch is the first listed.
NCT06083181 lists 7 locations in 6 states (Virginia, California, Kentucky).
Frequently Asked Questions
What is clinical trial NCT06083181 about?
NCT06083181 is a clinical study titled "Perf-Fix Study for Chronic Tympanic Membrane Repair". 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.
What is the current status of trial NCT06083181?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 88 participants. The study started on 2024-04-04. Estimated completion is 2026-03.
What conditions does trial NCT06083181 study?
This clinical trial studies the following conditions: Tympanic Membrane Perforation.
What interventions are being tested in trial NCT06083181?
The interventions under investigation include: Perf-Fix Otologic Gel Patch (DEVICE).
Who is sponsoring clinical trial NCT06083181?
This trial is sponsored by Tympanogen, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06083181 being conducted?
This trial has 7 study locations across California, Kentucky, Louisiana, Massachusetts, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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