Trials / Completed
CompletedNCT06083181
Perf-Fix Study for Chronic Tympanic Membrane Repair
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 71 (actual)
- Sponsor
- Tympanogen · Industry
- Sex
- All
- Age
- 5 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Perf-Fix Otologic Gel Patch | Gel patch application |
Timeline
- Start date
- 2024-04-05
- Primary completion
- 2026-01-30
- Completion
- 2026-01-30
- First posted
- 2023-10-13
- Last updated
- 2026-04-16
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06083181. Inclusion in this directory is not an endorsement.