Clinical trial NCT01589822: The EVICEL® Gastrointestinal Study
Official title: A Single Blind, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL® as an Adjunct to Gastrointestinal Anastomosis Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastrointestinal Diseases
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
First posted: 2012-05-02
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Absence of Gastrointestinal (GI) Leak
timeFrame: 40 days
Secondary outcomes:
measure: Incidence of Adverse Events
timeFrame: up to Day 90
measure: Incidence of GI Leak
timeFrame: 90 days
measure: Incidence of Stricture
timeFrame: up to Day 90
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Clinical Investigation Site #1
state: California
city: Jacksonville
country: United States
facility: Clinical Investigation Site #2
state: Florida
city: Augusta
country: United States
facility: Clinical Investigation Site #5
state: Georgia
city: New Orleans
country: United States
facility: Clinical Investigation Site #4
state: Louisiana
city: Portland
country: United States
facility: Clinical Investigation Site #8
state: Oregon
city: Greenville
country: United States
facility: Clinical Investigation Site #23
state: South Carolina
city: Houston
country: United States
facility: Clinical Investigation Site #3
state: Texas
city: Houston
country: United States
facility: Clinical Investigation Site #6
state: Texas
city: New Lambton
country: Australia
facility: Clinical Investigation Site #19
state: New South Wales
city: South Adelaide
country: Australia
facility: Clinical Investigation Site #18
city: Genk
country: Belgium
facility: Clinical Investigation Site #17
city: Ghent
country: Belgium
facility: Clinical Investigation Site #16
city: Vancouver
country: Canada
facility: Clinical Investigation Site #10
state: British Columbia
city: Toronto
country: Canada
facility: Clinical Investigation Site #9
state: Ontario
city: Seoul
country: Korea, Republic of
facility: Clinical Investigation Site #22
city: Seoul
country: Korea, Republic of
facility: Clinical Investigation Site #21
city: Auckland
country: New Zealand
facility: Clinical Investigation Site #20
city: Edinburgh
country: United Kingdom
facility: Clinical Investigation Site #15
city: Leicester
country: United Kingdom
facility: Clinical Investigation Site #11
city: Nottingham
country: United Kingdom
facility: Clinical Investigation Site #12
city: Plymouth
country: United Kingdom
facility: Clinical Investigation Site #13
city: Sheffield
country: United Kingdom
facility: Clinical Investigation Site #14
Study officials:
affiliation: Ethicon, Inc.
name: Richard Kocharian, MD
role: STUDY_DIRECTOR
References: