Trials / Completed
CompletedNCT03566602
Evaluate the Safety and Performance of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery
Single-arm, Open-label, Multicenter Study to Evaluate the Safety and Performance of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Polyganics BV · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of the study is to clinically assess the safety and performance of the Dura Sealant Patch as a means of reducing intra- as well as post-operative CSF leakage in patients undergoing elective cranial intradural surgery with a dural closure procedure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Dura Sealant Patch | Adjunctive bioresorbable patch |
Timeline
- Start date
- 2018-10-11
- Primary completion
- 2019-08-31
- Completion
- 2020-08-26
- First posted
- 2018-06-25
- Last updated
- 2020-09-16
Locations
3 sites across 2 countries: Netherlands, Switzerland
Source: ClinicalTrials.gov record NCT03566602. Inclusion in this directory is not an endorsement.