The EVICEL® Gastrointestinal Study

Phase 2

Completed

• Conditions: Gastrointestinal Diseases
• Interventions: Biological: EVICEL Fibrin Sealant

• Registration Number: NCT01589822
• Lead Sponsor: Ethicon, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2012-04-30
• Study First Submitted QC: 2012-05-01
• Study First Posted: 2012-05-02
• Study Start: 2012-06
• Primary Completion: 2014-01
• Results First Submitted: 2014-07-16
• Study Completion: 2014-09
• Status Verified: 2015-02
• Results First Submitted QC: 2015-02-24
• Last Update Submitted: 2015-02-24
• Results First Posted: 2015-02-25
• Last Update Posted: 2015-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 214

Inclusion Criteria

• Subjects undergoing primary elective GI surgery
• Subjects ≥ 18 years of age who are willing to participate in the study and provide written informed consent prior to any study-related procedures

Exclusion Criteria

• Avastin use within 30 days prior to surgery;
• Known hypersensitivity to the human blood products or the components of the investigational product;
• Female subjects who are pregnant or nursing;
• Exposure to another investigational drug or device in a clinical trial within 30 days prior to surgery or planned/intended for the 90 day follow up period after surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EVICEL Fibrin Sealant: Randomized	EVICEL Fibrin Sealant	EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.
Experimental: EVICEL Fibrin Sealant: Non-Randomized	EVICEL Fibrin Sealant	EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen

Primary Outcome Measures

Name	Time	Method
Absence of Gastrointestinal (GI) Leak	40 days

Secondary Outcome Measures

Name	Time	Method
Incidence of Adverse Events	up to Day 90
Incidence of GI Leak	90 days
Incidence of Stricture	up to Day 90

Trial Locations

Locations (22)

Clinical Investigation Site #1; 🇺🇸 Irvine, California, United States

Clinical Investigation Site #5; 🇺🇸 Augusta, Georgia, United States

Clinical Investigation Site #2; 🇺🇸 Jacksonville, Florida, United States

Clinical Investigation Site #23; 🇺🇸 Greenville, South Carolina, United States

Clinical Investigation Site #19; 🇦🇺 New Lambton, New South Wales, Australia

Clinical Investigation Site #6; 🇺🇸 Houston, Texas, United States

Clinical Investigation Site #17; 🇧🇪 Genk, Belgium

Clinical Investigation Site #16; 🇧🇪 Ghent, Belgium

Clinical Investigation Site #18; 🇦🇺 South Adelaide, Australia

Clinical Investigation Site #10; 🇨🇦 Vancouver, British Columbia, Canada

Clinical Investigation Site #22; 🇰🇷 Seoul, Korea, Republic of

Clinical Investigation Site #20; 🇳🇿 Auckland, New Zealand

Clinical Investigation Site #21; 🇰🇷 Seoul, Korea, Republic of

Clinical Investigation Site #11; 🇬🇧 Leicester, United Kingdom

Clinical Investigation Site #12; 🇬🇧 Nottingham, United Kingdom

Clinical Investigation Site #15; 🇬🇧 Edinburgh, United Kingdom

Clinical Investigation Site #13; 🇬🇧 Plymouth, United Kingdom

Clinical Investigation Site #14; 🇬🇧 Sheffield, United Kingdom

Clinical Investigation Site #9; 🇨🇦 Toronto, Ontario, Canada

Clinical Investigation Site #4; 🇺🇸 New Orleans, Louisiana, United States

Clinical Investigation Site #8; 🇺🇸 Portland, Oregon, United States

Clinical Investigation Site #3; 🇺🇸 Houston, Texas, United States