Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
214 participants
INTERVENTIONAL
2012-06-30
2014-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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EVICEL Fibrin Sealant: Randomized
EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.
EVICEL Fibrin Sealant
Intraoperative
Standard of Care
Standard surgical technique for GI anastomosis.
No interventions assigned to this group
Experimental: EVICEL Fibrin Sealant: Non-Randomized
EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen
EVICEL Fibrin Sealant
Intraoperative
Interventions
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EVICEL Fibrin Sealant
Intraoperative
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Ethicon, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Richard Kocharian, MD
Role: STUDY_DIRECTOR
Ethicon, Inc.
Locations
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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
Countries
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Other Identifiers
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400-11-002
Identifier Type: -
Identifier Source: org_study_id
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