The EVICEL® Gastrointestinal Study
The purpose of this study is to evaluate the safety and effectiveness of EVICEL® Fibrin Sealant (Human) for use as an adjunct to gastrointestinal (GI) surgery.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||A Single Blind, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL® as an Adjunct to Gastrointestinal Anastomosis Techniques|
- Absence of gastrointestinal (GI) leak [ Time Frame: 40 days ] [ Designated as safety issue: Yes ]
- Incidence of adverse events [ Time Frame: up to Day 90 ] [ Designated as safety issue: Yes ]
- Incidence of GI leak [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
- Incidence of stricture [ Time Frame: up to Day 90 ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||October 2014|
|Estimated Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Experimental: EVICEL Fibrin Sealant
EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.
Biological: EVICEL Fibrin Sealant
Other Name: Fibrin sealant
No Intervention: Standard of Care
Standard surgical technique for GI anastomosis.
This is a single blind, randomized, multi-center controlled study evaluating the safety and effectiveness of EVICEL® when used as an adjunct to gastrointestinal (GI) surgery.
Show 23 Study Locations
|Study Director:||Richard Kocharian, MD||Ethicon, Inc.|