Suturable DuraGen™ PMCF Study
NCT04923867 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 106
Last updated 2025-04-06
Summary
The primary goal of this study is to retrospectively collect data on the safety and efficacy of Suturable DuraGen™.
Conditions
- Cerebrospinal Fluid Leak
Interventions
- DEVICE
-
Suturable DuraGen™
Suturable DuraGen™ Dural Regeneration Matrix, an absorbable implant for repair of dural defects.
Sponsors & Collaborators
-
Integra LifeSciences Corporation
lead INDUSTRY
Principal Investigators
-
Andrew Tummon · Integra LifeSciences
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-04-28
- Primary Completion
- 2024-07-31
- Completion
- 2024-07-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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