Trials / Completed
CompletedNCT02457546
The EVICEL® Neurosurgery Phase III Study
A Single-Blinded, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL® Fibrin Sealant (Human) Compared to a Hydrogel Sealant as an Adjunct to Sutured Dural Repair
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 234 (actual)
- Sponsor
- Ethicon, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to evaluate the safety and efficacy of EVICEL® Fibrin Sealant (Human) for use as an adjunct to sutured dural repair in cranial surgery.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | EVICEL Fibrin Sealant | |
| DEVICE | Hydrogel sealant |
Timeline
- Start date
- 2015-07-01
- Primary completion
- 2017-09-13
- Completion
- 2017-10-12
- First posted
- 2015-05-29
- Last updated
- 2019-01-10
- Results posted
- 2018-12-04
Locations
26 sites across 6 countries: United States, Australia, Belgium, Canada, New Zealand, United Kingdom
Source: ClinicalTrials.gov record NCT02457546. Inclusion in this directory is not an endorsement.