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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014