NCT01589822

The EVICEL® Gastrointestinal Study

A Single Blind, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL® as an Adjunct to Gastrointestinal Anastomosis Techniques

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 214 (actual)
• Sponsor: Ethicon, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Gastrointestinal Diseases

Interventions

Type	Name	Description
BIOLOGICAL	EVICEL Fibrin Sealant	Intraoperative

Timeline

• Start date: 2012-06-01
• Primary completion: 2014-01-01
• Completion: 2014-09-01
• First posted: 2012-05-02
• Last updated: 2015-02-25
• Results posted: 2015-02-25

Locations

22 sites across 7 countries: United States, Australia, Belgium, Canada, New Zealand, South Korea, United Kingdom