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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Other interventions - 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


Other interventions: EVICEL Fibrin Sealant
Intraoperative
Intervention code [1] 0 0
Other interventions
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
1/06/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2014
Sample size
Target
Accrual to date
Final
214
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
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 website
https://clinicaltrials.gov/ct2/show/NCT01589822
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01589822