Trials / Completed
CompletedNCT04086550
Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery
Randomized, Two-arm, Multicenter Study to Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 228 (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 effectiveness of LIQOSEAL® 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 to show noninferiority compared to a control group.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | LIQOSEAL | Adjunctive bioresorbable patch |
| DEVICE | DuraSeal, Adherus | synthetic absorbable sealants |
Timeline
- Start date
- 2021-05-20
- Primary completion
- 2024-02-13
- Completion
- 2024-02-13
- First posted
- 2019-09-11
- Last updated
- 2024-06-26
Locations
17 sites across 7 countries: United States, Austria, Belgium, Germany, Italy, Netherlands, Switzerland
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04086550. Inclusion in this directory is not an endorsement.