The EVICEL® Gastrointestinal Study

Ethicon

Status and phase: Completed; Phase 2

Conditions: Gastrointestinal Diseases

Treatments: Biological: EVICEL Fibrin Sealant

Study type: Interventional

Funder types: Industry

Identifiers

NCT01589822

400-11-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 214 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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214 participants in 3 patient groups

EVICEL Fibrin Sealant: Randomized

Experimental group

Description:

EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.

Treatment:

Biological: EVICEL Fibrin Sealant

Standard of Care

No Intervention group

Description:

Standard surgical technique for GI anastomosis.

Experimental: EVICEL Fibrin Sealant: Non-Randomized

Experimental group

Description:

EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen

Treatment:

Biological: EVICEL Fibrin Sealant