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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01589822
Registration number
NCT01589822
Ethics application status
Date submitted
30/04/2012
Date registered
2/05/2012
Date last updated
25/02/2015
Titles & IDs
Public title
The EVICEL® Gastrointestinal Study
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Scientific title
A Single Blind, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL® as an Adjunct to Gastrointestinal Anastomosis Techniques
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Secondary ID [1]
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400-11-002
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal Diseases
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - EVICEL Fibrin Sealant
Experimental: EVICEL Fibrin Sealant: Randomized - EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.
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
Treatment: Other: EVICEL Fibrin Sealant
Intraoperative
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Absence of Gastrointestinal (GI) Leak
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Assessment method [1]
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Timepoint [1]
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40 days
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Secondary outcome [1]
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Incidence of Adverse Events
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Assessment method [1]
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Timepoint [1]
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up to Day 90
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Secondary outcome [2]
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Incidence of GI Leak
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Assessment method [2]
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Timepoint [2]
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90 days
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Secondary outcome [3]
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Incidence of Stricture
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Assessment method [3]
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Timepoint [3]
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up to Day 90
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2014
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Sample size
Target
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Accrual to date
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Final
214
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Clinical Investigation Site #19 - New Lambton
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Recruitment hospital [2]
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Clinical Investigation Site #18 - South Adelaide
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Recruitment postcode(s) [1]
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2305 - New Lambton
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Recruitment postcode(s) [2]
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6010 - South Adelaide
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Recruitment outside Australia
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United States of America
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State/province [1]
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California
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Louisiana
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United States of America
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Oregon
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United States of America
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South Carolina
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United States of America
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Texas
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Belgium
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Genk
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Belgium
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Ghent
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Canada
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British Columbia
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Canada
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Ontario
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Korea, Republic of
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Seoul
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New Zealand
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Auckland
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United Kingdom
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Edinburgh
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United Kingdom
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Leicester
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United Kingdom
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Nottingham
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United Kingdom
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Plymouth
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United Kingdom
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State/province [18]
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Sheffield
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Ethicon, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT01589822
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Richard Kocharian, MD
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Address
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Ethicon, Inc.
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01589822
Download to PDF