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The EVICEL® Gastrointestinal Study

NCT01589822 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2015-02-25

Study results available
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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.

Conditions

  • Gastrointestinal Diseases

Interventions

BIOLOGICAL

EVICEL Fibrin Sealant

Intraoperative

Sponsors & Collaborators

  • Ethicon, Inc.

    lead INDUSTRY

Principal Investigators

  • Richard Kocharian, MD · Ethicon, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2014-01-31
Completion
2014-09-30

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • New Zealand
  • South Korea
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01589822 on ClinicalTrials.gov