The EVICEL® Gastrointestinal Study

Completed · Phase 2

Conditions studied: Gastrointestinal Diseases

In brief

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.

Key facts

Study ID

NCT01589822

Run by

Ethicon, Inc.

People needed

214

Starts

2012-06-01

Expected to finish

2014-09-01

Last updated by the study team

2015-02-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Clinical Investigation Site #1 — Irvine, California, United States
• Clinical Investigation Site #2 — Jacksonville, Florida, United States
• Clinical Investigation Site #5 — Augusta, Georgia, United States
• Clinical Investigation Site #4 — New Orleans, Louisiana, United States
• Clinical Investigation Site #8 — Portland, Oregon, United States
• Clinical Investigation Site #23 — Greenville, South Carolina, United States
• Clinical Investigation Site #3 — Houston, Texas, United States
• Clinical Investigation Site #6 — Houston, Texas, United States
• Clinical Investigation Site #19 — New Lambton, New South Wales, Australia
• Clinical Investigation Site #18 — South Adelaide, Australia
• Clinical Investigation Site #17 — Genk, Belgium
• Clinical Investigation Site #16 — Ghent, Belgium
• Clinical Investigation Site #10 — Vancouver, British Columbia, Canada
• Clinical Investigation Site #9 — Toronto, Ontario, Canada
• Clinical Investigation Site #20 — Auckland, New Zealand
• Clinical Investigation Site #22 — Seoul, South Korea
• Clinical Investigation Site #21 — Seoul, South Korea
• Clinical Investigation Site #15 — Edinburgh, United Kingdom
• Clinical Investigation Site #11 — Leicester, United Kingdom
• Clinical Investigation Site #12 — Nottingham, United Kingdom
• Clinical Investigation Site #13 — Plymouth, United Kingdom
• Clinical Investigation Site #14 — Sheffield, United Kingdom

Full record on ClinicalTrials.gov

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