Back to resultsThe EVICEL® Gastrointestinal Study
Primary Purpose
Gastrointestinal Diseases
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
EVICEL Fibrin Sealant
Sponsored by
About this trial
This is an interventional treatment trial for Gastrointestinal Diseases
Eligibility Criteria
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.
Sites / Locations
- Clinical Investigation Site #1
- Clinical Investigation Site #2
- Clinical Investigation Site #5
- Clinical Investigation Site #4
- Clinical Investigation Site #8
- Clinical Investigation Site #23
- Clinical Investigation Site #3
- Clinical Investigation Site #6
- Clinical Investigation Site #19
- Clinical Investigation Site #18
- Clinical Investigation Site #17
- Clinical Investigation Site #16
- Clinical Investigation Site #10
- Clinical Investigation Site #9
- Clinical Investigation Site #22
- Clinical Investigation Site #21
- Clinical Investigation Site #20
- Clinical Investigation Site #15
- Clinical Investigation Site #11
- Clinical Investigation Site #12
- Clinical Investigation Site #13
- Clinical Investigation Site #14
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
Experimental
Arm Label
EVICEL Fibrin Sealant: Randomized
Standard of Care
Experimental: EVICEL Fibrin Sealant: Non-Randomized
Arm Description
EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.
Standard surgical technique for GI anastomosis.
EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen
Outcomes
Primary Outcome Measures
Absence of Gastrointestinal (GI) Leak
Secondary Outcome Measures
Incidence of Adverse Events
Incidence of GI Leak
Incidence of Stricture
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01589822
Brief Title
The EVICEL® Gastrointestinal Study
Official Title
A Single Blind, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL® as an Adjunct to Gastrointestinal Anastomosis Techniques
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ethicon, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
214 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EVICEL Fibrin Sealant: Randomized
Arm Type
Experimental
Arm Description
EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Standard surgical technique for GI anastomosis.
Arm Title
Experimental: EVICEL Fibrin Sealant: Non-Randomized
Arm Type
Experimental
Arm Description
EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen
Intervention Type
Biological
Intervention Name(s)
EVICEL Fibrin Sealant
Other Intervention Name(s)
Fibrin sealant
Intervention Description
Intraoperative
Primary Outcome Measure Information:
Title
Absence of Gastrointestinal (GI) Leak
Time Frame
40 days
Secondary Outcome Measure Information:
Title
Incidence of Adverse Events
Time Frame
up to Day 90
Title
Incidence of GI Leak
Time Frame
90 days
Title
Incidence of Stricture
Time Frame
up to Day 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Kocharian, MD
Organizational Affiliation
Ethicon, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Investigation Site #1
City
Irvine
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Clinical Investigation Site #2
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32099
Country
United States
Facility Name
Clinical Investigation Site #5
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Clinical Investigation Site #4
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Clinical Investigation Site #8
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Clinical Investigation Site #23
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Clinical Investigation Site #3
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Clinical Investigation Site #6
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Clinical Investigation Site #19
City
New Lambton
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Facility Name
Clinical Investigation Site #18
City
South Adelaide
ZIP/Postal Code
6010
Country
Australia
Facility Name
Clinical Investigation Site #17
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Clinical Investigation Site #16
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Clinical Investigation Site #10
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
Clinical Investigation Site #9
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Clinical Investigation Site #22
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Clinical Investigation Site #21
City
Seoul
Country
Korea, Republic of
Facility Name
Clinical Investigation Site #20
City
Auckland
ZIP/Postal Code
0622
Country
New Zealand
Facility Name
Clinical Investigation Site #15
City
Edinburgh
ZIP/Postal Code
EH42XU
Country
United Kingdom
Facility Name
Clinical Investigation Site #11
City
Leicester
ZIP/Postal Code
LE15WW
Country
United Kingdom
Facility Name
Clinical Investigation Site #12
City
Nottingham
ZIP/Postal Code
NG72UH
Country
United Kingdom
Facility Name
Clinical Investigation Site #13
City
Plymouth
ZIP/Postal Code
PL68DH
Country
United Kingdom
Facility Name
Clinical Investigation Site #14
City
Sheffield
ZIP/Postal Code
S57AU
Country
United Kingdom
12. IPD Sharing Statement
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The EVICEL® Gastrointestinal Study
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