The EVICEL® Gastrointestinal Study

Ethicon, Inc.214 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

214

Conditions

Gastrointestinal Diseases

Interventions

EVICEL Fibrin SealantBIOLOGICAL

Intraoperative

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (22)

Clinical Investigation Site #1

Irvine, California, United States

Outcomes

Primary Outcomes

Absence of Gastrointestinal (GI) Leak

Time frame: 40 days

Secondary Outcomes

Incidence of Adverse Events

Time frame: up to Day 90

Incidence of GI Leak

Time frame: 90 days

Incidence of Stricture

Time frame: up to Day 90

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.