Trials / Completed
CompletedNCT01158261
The Evicel Post-Authorization Surveillance Study
A Prospective, Single-Arm, Observational, Non-interventional Study for EVICEL ™ Fibrin Sealant (Human) When Used as an Adjunct to Haemostasis in Vascular Surgery
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 300 (actual)
- Sponsor
- Ethicon, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | EVICEL ™ Fibrin Sealant (Human) | Commercial Evicel |
Timeline
- Start date
- 2010-06-01
- Primary completion
- 2014-04-01
- Completion
- 2014-05-01
- First posted
- 2010-07-08
- Last updated
- 2015-08-19
- Results posted
- 2015-08-19
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01158261. Inclusion in this directory is not an endorsement.