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

April 30, 2012
November 19, 2013
June 2012
November 2013   (final data collection date for primary outcome measure)
Absence of gastrointestinal (GI) leak [ Time Frame: 40 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01589822 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
The EVICEL® Gastrointestinal Study
A Single Blind, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL® as an Adjunct to Gastrointestinal Anastomosis Techniques

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Gastrointestinal Diseases
Biological: EVICEL Fibrin Sealant
Intraoperative
Other Name: Fibrin sealant
  • Experimental: EVICEL Fibrin Sealant
    EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.
    Intervention: Biological: EVICEL Fibrin Sealant
  • No Intervention: Standard of Care
    Standard surgical technique for GI anastomosis.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
150
October 2014
November 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Canada,   Korea, Republic of,   New Zealand,   United Kingdom
 
NCT01589822
400-11-002
Yes
Ethicon, Inc.
Ethicon, Inc.
Not Provided
Study Director: Richard Kocharian, MD Ethicon, Inc.
Ethicon, Inc.
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP