- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01589822
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
Conditions
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
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South Adelaide, Australia, 6010
- Clinical Investigation Site #18
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New South Wales
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New Lambton, New South Wales, Australia, 2305
- Clinical Investigation Site #19
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Genk, Belgium, 3600
- Clinical Investigation Site #17
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Ghent, Belgium, 9000
- Clinical Investigation Site #16
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British Columbia
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Vancouver, British Columbia, Canada, V6Z 1Y6
- Clinical Investigation Site #10
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Ontario
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Toronto, Ontario, Canada, M5G 1X5
- Clinical Investigation Site #9
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Seoul, Korea, Republic of, 138-736
- Clinical Investigation Site #22
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Seoul, Korea, Republic of
- Clinical Investigation Site #21
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Auckland, New Zealand, 0622
- Clinical Investigation Site #20
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Edinburgh, United Kingdom, EH42XU
- Clinical Investigation Site #15
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Leicester, United Kingdom, LE15WW
- Clinical Investigation Site #11
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Nottingham, United Kingdom, NG72UH
- Clinical Investigation Site #12
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Plymouth, United Kingdom, PL68DH
- Clinical Investigation Site #13
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Sheffield, United Kingdom, S57AU
- Clinical Investigation Site #14
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California
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Irvine, California, United States, 92868
- Clinical Investigation Site #1
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Florida
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Jacksonville, Florida, United States, 32099
- Clinical Investigation Site #2
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Georgia
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Augusta, Georgia, United States, 30912
- Clinical Investigation Site #5
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Louisiana
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New Orleans, Louisiana, United States, 70121
- Clinical Investigation Site #4
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Oregon
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Portland, Oregon, United States, 97239
- Clinical Investigation Site #8
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South Carolina
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Greenville, South Carolina, United States, 29605
- Clinical Investigation Site #23
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Texas
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Houston, Texas, United States, 77030
- Clinical Investigation Site #3
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Houston, Texas, United States, 77030
- Clinical Investigation Site #6
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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 |
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Experimental: EVICEL Fibrin Sealant: Randomized
EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.
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Intraoperative
Other Names:
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No Intervention: Standard of Care
Standard surgical technique for GI anastomosis.
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Experimental: Experimental: EVICEL Fibrin Sealant: Non-Randomized
EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen
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Intraoperative
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Absence of Gastrointestinal (GI) Leak
Time Frame: 40 days
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40 days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Incidence of Adverse Events
Time Frame: up to Day 90
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up to Day 90
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Incidence of GI Leak
Time Frame: 90 days
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90 days
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Incidence of Stricture
Time Frame: up to Day 90
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up to Day 90
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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
Additional Relevant MeSH Terms
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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