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Clinical Trials/NCT01589822
NCT01589822
Completed
Phase 2

A Single Blind, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL® as an Adjunct to Gastrointestinal Anastomosis Techniques

Ethicon, Inc.22 sites in 7 countries214 target enrollmentJune 2012
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ConditionsGastrointestinal Diseases

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Gastrointestinal Diseases
Sponsor
Ethicon, Inc.
Enrollment
214
Locations
22
Primary Endpoint
Absence of Gastrointestinal (GI) Leak
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
June 2012
End Date
September 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

Absence of Gastrointestinal (GI) Leak

Time Frame: 40 days

Secondary Outcomes

  • Incidence of Stricture(up to Day 90)
  • Incidence of Adverse Events(up to Day 90)
  • Incidence of GI Leak(90 days)

Study Sites (22)

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