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

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.