Trials / Completed
CompletedNCT02034799
Phase IV Bioseal Study in Brain Tumor Surgery
A Prospective, Randomized, Controlled Phase IV Study to Compare Bioseal Versus Standard of Care as an Adjunct to Hemostasis in Elective Brain Tumor Surgery
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 256 (actual)
- Sponsor
- Ethicon, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to observe the clinical utility and performance of Bioseal when used as an adjunct to hemostasis versus Standard of Care (SoC) in elective meningioma surgery.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Bioseal Fibrin Sealant | |
| OTHER | Standard of Care (SoC) |
Timeline
- Start date
- 2013-11-01
- Primary completion
- 2014-08-01
- Completion
- 2014-09-01
- First posted
- 2014-01-14
- Last updated
- 2018-02-26
- Results posted
- 2018-02-26
Locations
7 sites across 1 country: China
Source: ClinicalTrials.gov record NCT02034799. Inclusion in this directory is not an endorsement.