The EVICEL® Gastrointestinal Study

February 24, 2015 updated by: Ethicon, Inc.

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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

214

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • South Adelaide, Australia, 6010
        • Clinical Investigation Site #18
    • New South Wales
      • New Lambton, New South Wales, Australia, 2305
        • Clinical Investigation Site #19
      • Genk, Belgium, 3600
        • Clinical Investigation Site #17
      • Ghent, Belgium, 9000
        • Clinical Investigation Site #16
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Clinical Investigation Site #10
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X5
        • Clinical Investigation Site #9
      • Seoul, Korea, Republic of, 138-736
        • Clinical Investigation Site #22
      • Seoul, Korea, Republic of
        • Clinical Investigation Site #21
      • Auckland, New Zealand, 0622
        • Clinical Investigation Site #20
      • Edinburgh, United Kingdom, EH42XU
        • Clinical Investigation Site #15
      • Leicester, United Kingdom, LE15WW
        • Clinical Investigation Site #11
      • Nottingham, United Kingdom, NG72UH
        • Clinical Investigation Site #12
      • Plymouth, United Kingdom, PL68DH
        • Clinical Investigation Site #13
      • Sheffield, United Kingdom, S57AU
        • Clinical Investigation Site #14
    • California
      • Irvine, California, United States, 92868
        • Clinical Investigation Site #1
    • Florida
      • Jacksonville, Florida, United States, 32099
        • Clinical Investigation Site #2
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Clinical Investigation Site #5
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Clinical Investigation Site #4
    • Oregon
      • Portland, Oregon, United States, 97239
        • Clinical Investigation Site #8
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Clinical Investigation Site #23
    • Texas
      • Houston, Texas, United States, 77030
        • Clinical Investigation Site #3
      • Houston, Texas, United States, 77030
        • Clinical Investigation Site #6

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EVICEL Fibrin Sealant: Randomized
EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.
Intraoperative
Other Names:
  • Fibrin sealant
No Intervention: Standard of Care
Standard surgical technique for GI anastomosis.
Experimental: Experimental: EVICEL Fibrin Sealant: Non-Randomized
EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen
Intraoperative
Other Names:
  • Fibrin sealant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Absence of Gastrointestinal (GI) Leak
Time Frame: 40 days
40 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of Adverse Events
Time Frame: up to Day 90
up to Day 90
Incidence of GI Leak
Time Frame: 90 days
90 days
Incidence of Stricture
Time Frame: up to Day 90
up to Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

April 30, 2012

First Submitted That Met QC Criteria

May 1, 2012

First Posted (Estimate)

May 2, 2012

Study Record Updates

Last Update Posted (Estimate)

February 25, 2015

Last Update Submitted That Met QC Criteria

February 24, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 400-11-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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