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

Use our guide to learn which trials are right for you!

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
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
?
mi
from
Augusta, GA
Click here to add this to my saved trials
Greenville, South Carolina 29605
?
mi
from
Greenville, SC
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Irvine, CA
Click here to add this to my saved trials
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
?
mi
from
Portland, OR
Click here to add this to my saved trials
?
mi
from
Stanford, CA
Click here to add this to my saved trials