Trials / Completed
CompletedNCT04923867
Suturable DuraGen™ PMCF Study
A Multicenter, Retrospective, Post-Market Clinical Follow-Up Study to Evaluate the Performance and Safety of Suturable DuraGen™
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 106 (actual)
- Sponsor
- Integra LifeSciences Corporation · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The primary goal of this study is to retrospectively collect data on the safety and efficacy of Suturable DuraGen™.
Detailed description
This is a multicenter, non-randomized, non-interventional, retrospective Post-Market Clinical Follow-up (PMCF) study to evaluate the occurrence of post-operative cerebrospinal fluid (CSF) leaks within 30 days (and up to 90 days) after use of Suturable DuraGen™ for a supratentorial, infratentorial, or spinal procedure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Suturable DuraGen™ | Suturable DuraGen™ Dural Regeneration Matrix, an absorbable implant for repair of dural defects. |
Timeline
- Start date
- 2021-04-28
- Primary completion
- 2024-07-31
- Completion
- 2024-07-31
- First posted
- 2021-06-11
- Last updated
- 2025-04-06
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04923867. Inclusion in this directory is not an endorsement.