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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
Scientific title
A Single Blind, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL® as an Adjunct to Gastrointestinal Anastomosis Techniques
Secondary ID [1] 0 0
400-11-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal Diseases 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Absence of Gastrointestinal (GI) Leak
Timepoint [1] 0 0
40 days
Secondary outcome [1] 0 0
Incidence of Adverse Events
Timepoint [1] 0 0
up to Day 90
Secondary outcome [2] 0 0
Incidence of GI Leak
Timepoint [2] 0 0
90 days
Secondary outcome [3] 0 0
Incidence of Stricture
Timepoint [3] 0 0
up to Day 90

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Clinical Investigation Site #19 - New Lambton
Recruitment hospital [2] 0 0
Clinical Investigation Site #18 - South Adelaide
Recruitment postcode(s) [1] 0 0
2305 - New Lambton
Recruitment postcode(s) [2] 0 0
6010 - South Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Oregon
Country [6] 0 0
United States of America
State/province [6] 0 0
South Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Belgium
State/province [8] 0 0
Genk
Country [9] 0 0
Belgium
State/province [9] 0 0
Ghent
Country [10] 0 0
Canada
State/province [10] 0 0
British Columbia
Country [11] 0 0
Canada
State/province [11] 0 0
Ontario
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Seoul
Country [13] 0 0
New Zealand
State/province [13] 0 0
Auckland
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Edinburgh
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Leicester
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Nottingham
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Plymouth
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ethicon, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Richard Kocharian, MD
Address 0 0
Ethicon, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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.