Trials / Completed
CompletedNCT04635228
Biodesign® Otologic Repair Graft
Post-market Real-world Collection Data for the Biodesign® Otologic Repair Graft
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 87 (actual)
- Sponsor
- Cook Research Incorporated · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The post-market follow-up clinical trial of the Cook® Biodesign® Otologic Repair Graft will follow patients up to 3 months post-implantation to determine the percent of patients with complete closure of the tympanic membrane.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Biodesign Otologic Repair Graft | The Biodesign Otologic Repair Graft is intended for use as grafting material for tympanic membrane perforation closure. |
Timeline
- Start date
- 2021-09-29
- Primary completion
- 2025-12-23
- Completion
- 2025-12-23
- First posted
- 2020-11-19
- Last updated
- 2026-01-07
Locations
5 sites across 2 countries: United States, United Kingdom
Source: ClinicalTrials.gov record NCT04635228. Inclusion in this directory is not an endorsement.