Trials / Completed
CompletedNCT02040428
The Fibrin Pad CV Phase III Study
A Single-blinded, Randomized, Controlled, Comparative Phase III Study Evaluating the Safety and Effectiveness of EVARREST™ Fibrin Sealant Patch as an Adjunct to Hemostasis During Cardiovascular Surgery
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 156 (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 effectiveness of the EVARREST™ Fibrin Sealant Patch as an adjunct to hemostasis during cardiovascular surgery.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | EVARREST™ Fibrin Sealant Patch | |
| BIOLOGICAL | Topical hemostat |
Timeline
- Start date
- 2014-01-01
- Primary completion
- 2015-07-01
- Completion
- 2015-09-01
- First posted
- 2014-01-20
- Last updated
- 2017-08-15
- Results posted
- 2017-08-15
Locations
24 sites across 5 countries: United States, Australia, Belgium, Japan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02040428. Inclusion in this directory is not an endorsement.