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 |
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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