The EVICEL® Gastrointestinal Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT01589822
First received: April 30, 2012
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Gastrointestinal Diseases
Biological: EVICEL Fibrin Sealant
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Single Blind, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL® as an Adjunct to Gastrointestinal Anastomosis Techniques

Resource links provided by NLM:


Further study details as provided by Ethicon, Inc.:

Primary Outcome Measures:
  • Absence of gastrointestinal (GI) leak [ Time Frame: 40 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of adverse events [ Time Frame: up to Day 90 ] [ Designated as safety issue: Yes ]
  • Incidence of GI leak [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • Incidence of stricture [ Time Frame: up to Day 90 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: June 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EVICEL Fibrin Sealant
EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.
Biological: EVICEL Fibrin Sealant
Intraoperative
Other Name: Fibrin sealant
No Intervention: Standard of Care
Standard surgical technique for GI anastomosis.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01589822

  Hide Study Locations
Locations
United States, California
Clinical Investigation Site #1
Irvine, California, United States, 92868
Clinical Investigation Site #7
Stanford, California, United States, 94305
United States, Florida
Clinical Investigation Site #2
Jacksonville, Florida, United States, 32099
United States, Georgia
Clinical Investigation Site #5
Augusta, Georgia, United States, 30912
United States, Louisiana
Clinical Investigation Site #4
New Orleans, Louisiana, United States, 70121
United States, Oregon
Clinical Investigation Site #8
Portland, Oregon, United States, 97239
United States, South Carolina
Clinical Investigation Site #23
Greenville, South Carolina, United States, 29605
United States, Texas
Clinical Investigation Site #3
Houston, Texas, United States, 77030
Clinical Investigation Site #6
Houston, Texas, United States, 77030
Australia, New South Wales
Clinical Investigation Site #19
New Lambton, New South Wales, Australia, 2305
Australia
Clinical Investigation Site #18
South Adelaide, Australia, 6010
Belgium
Clinical Investigation Site #17
Genk, Belgium, 3600
Clinical Investigation Site #16
Ghent, Belgium, 9000
Canada, British Columbia
Clinical Investigation Site #10
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Ontario
Clinical Investigation Site #9
Toronto, Ontario, Canada, M5G 1X5
Korea, Republic of
Clinical Investigation Site #21
Seoul, Korea, Republic of
Clinical Investigation Site #22
Seoul, Korea, Republic of, 138-736
New Zealand
Clinical Investigation Site #20
Auckland, New Zealand, 0622
United Kingdom
Clinical Investigation Site #15
Edinburgh, United Kingdom, EH42XU
Clinical Investigation Site #11
Leicester, United Kingdom, LE15WW
Clinical Investigation Site #12
Nottingham, United Kingdom, NG72UH
Clinical Investigation Site #13
Plymouth, United Kingdom, PL68DH
Clinical Investigation Site #14
Sheffield, United Kingdom, S57AU
Sponsors and Collaborators
Ethicon, Inc.
Investigators
Study Director: Richard Kocharian, MD Ethicon, Inc.
  More Information

No publications provided

Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT01589822     History of Changes
Other Study ID Numbers: 400-11-002
Study First Received: April 30, 2012
Last Updated: November 19, 2013
Health Authority: United States: Food and Drug Administration
Korea: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
New Zealand: Medsafe

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases
Fibrin Tissue Adhesive
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014