The EVICEL® Gastrointestinal Study
A Single Blind, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL® as an Adjunct to Gastrointestinal Anastomosis Techniques
1 other identifier
interventional
214
7 countries
22
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2012
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2012
CompletedFirst Posted
Study publicly available on registry
May 2, 2012
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedResults Posted
Study results publicly available
February 25, 2015
CompletedFebruary 25, 2015
February 1, 2015
1.6 years
April 30, 2012
July 16, 2014
February 24, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Absence of Gastrointestinal (GI) Leak
40 days
Secondary Outcomes (3)
Incidence of Adverse Events
up to Day 90
Incidence of GI Leak
90 days
Incidence of Stricture
up to Day 90
Study Arms (3)
EVICEL Fibrin Sealant: Randomized
EXPERIMENTALEVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.
Standard of Care
NO INTERVENTIONStandard surgical technique for GI anastomosis.
Experimental: EVICEL Fibrin Sealant: Non-Randomized
EXPERIMENTALEVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen
Interventions
Intraoperative
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ethicon, Inc.lead
Study Sites (22)
Clinical Investigation Site #1
Irvine, California, 92868, United States
Clinical Investigation Site #2
Jacksonville, Florida, 32099, United States
Clinical Investigation Site #5
Augusta, Georgia, 30912, United States
Clinical Investigation Site #4
New Orleans, Louisiana, 70121, United States
Clinical Investigation Site #8
Portland, Oregon, 97239, United States
Clinical Investigation Site #23
Greenville, South Carolina, 29605, United States
Clinical Investigation Site #3
Houston, Texas, 77030, United States
Clinical Investigation Site #6
Houston, Texas, 77030, United States
Clinical Investigation Site #19
New Lambton, New South Wales, 2305, Australia
Clinical Investigation Site #18
South Adelaide, 6010, Australia
Clinical Investigation Site #17
Genk, 3600, Belgium
Clinical Investigation Site #16
Ghent, 9000, Belgium
Clinical Investigation Site #10
Vancouver, British Columbia, V6Z 1Y6, Canada
Clinical Investigation Site #9
Toronto, Ontario, M5G 1X5, Canada
Clinical Investigation Site #20
Auckland, 0622, New Zealand
Clinical Investigation Site #22
Seoul, 138-736, South Korea
Clinical Investigation Site #21
Seoul, South Korea
Clinical Investigation Site #15
Edinburgh, EH42XU, United Kingdom
Clinical Investigation Site #11
Leicester, LE15WW, United Kingdom
Clinical Investigation Site #12
Nottingham, NG72UH, United Kingdom
Clinical Investigation Site #13
Plymouth, PL68DH, United Kingdom
Clinical Investigation Site #14
Sheffield, S57AU, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Clinical Development
- Organization
- Ethicon
Study Officials
- STUDY DIRECTOR
Richard Kocharian, MD
Ethicon, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2012
First Posted
May 2, 2012
Study Start
June 1, 2012
Primary Completion
January 1, 2014
Study Completion
September 1, 2014
Last Updated
February 25, 2015
Results First Posted
February 25, 2015
Record last verified: 2015-02