The EVICEL® Gastrointestinal Study



Status:Completed
Conditions:Gastrointestinal, Digestive Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:11/23/2013
Start Date:June 2012
End Date:July 2014
Contact:Jonathan Batiller
Email:jbatill2@its.jnj.com
Phone:908-218-2492

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


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.


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.

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.
We found this trial at
8
sites
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Houston, TX
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Augusta, GA
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Greenville, South Carolina 29605
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Greenville, SC
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Irvine, CA
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Jacksonville, FL
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New Orleans, LA
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Portland, OR
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Stanford, CA
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