The EVICEL® Gastrointestinal Study

Gastrointestinal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01589822
• Other study ID #: 400-11-002
• Status: Completed
• Phase: Phase 2
• First received: April 30, 2012
• Last updated: February 24, 2015
• Start date: June 2012
• Est. completion date: September 2014

Study information

• Verified date: February 2015
• Source: Ethicon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationKorea: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyBelgium: Federal Agency for Medicinal Products and Health ProductsCanada: Health CanadaNew Zealand: Medsafe
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: September 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases

Intervention

Biological:
• EVICEL Fibrin Sealant
Intraoperative

Locations

Country	Name	City	State
Australia	Clinical Investigation Site #19	New Lambton	New South Wales
Australia	Clinical Investigation Site #18	South Adelaide
Belgium	Clinical Investigation Site #17	Genk
Belgium	Clinical Investigation Site #16	Ghent
Canada	Clinical Investigation Site #9	Toronto	Ontario
Canada	Clinical Investigation Site #10	Vancouver	British Columbia
Korea, Republic of	Clinical Investigation Site #21	Seoul
Korea, Republic of	Clinical Investigation Site #22	Seoul
New Zealand	Clinical Investigation Site #20	Auckland
United Kingdom	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 States	Clinical Investigation Site #5	Augusta	Georgia
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 #1	Irvine	California
United States	Clinical Investigation Site #2	Jacksonville	Florida
United States	Clinical Investigation Site #4	New Orleans	Louisiana
United States	Clinical Investigation Site #8	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Korea, Republic of,  New Zealand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence of Gastrointestinal (GI) Leak		40 days	Yes
Secondary	Incidence of Adverse Events		up to Day 90	Yes
Secondary	Incidence of GI Leak		90 days	Yes
Secondary	Incidence of Stricture		up to Day 90	Yes