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

  Show 23 Study Locations
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 July 22, 2014