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Completed

NCT Number: NCT01589822

The EVICEL® Gastrointestinal Study

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.

Completed

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Key information

Conditions

Gastrointestinal Diseases Digestive System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Investigation Site #19, New Lambton, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EVICEL Fibrin Sealant

Biological

Intraoperative

Other names: Fibrin sealant

Primary outcomes

  1. Absence of Gastrointestinal (GI) Leak

    Time frame: 40 days

Secondary outcomes

  1. Incidence of Adverse Events

    Time frame: up to Day 90

  2. Incidence of GI Leak

    Time frame: 90 days

  3. Incidence of Stricture

    Time frame: up to Day 90

Sponsors and collaborators

Lead sponsor

Ethicon, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 2, 2012
Registry last updated
Feb 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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