The Evicel Post-Authorization Surveillance Study
NCT01158261 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 300
Last updated 2015-08-19
Summary
The objective of this non-interventional Post Authorisation Safety Surveillance (PASS) study is to observe the clinical safety performance of EVICEL when used as suture support for haemostasis in vascular surgery.
Conditions
- Peripheral Vascular Disease
- Hemorrhage
Interventions
- BIOLOGICAL
-
EVICEL ™ Fibrin Sealant (Human)
Commercial Evicel
Sponsors & Collaborators
-
OMRIX Biopharmaceuticals
collaborator INDUSTRY -
Ethicon, Inc.
lead INDUSTRY
Principal Investigators
-
Richard Kocharian, MD · Ethicon, Inc.
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-06-30
- Primary Completion
- 2014-04-30
- Completion
- 2014-05-31
Countries
- United States
Study Locations
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