The Evicel Post-Authorization Surveillance Study

July 22, 2015 updated by: Ethicon, Inc.

A Prospective, Single-Arm, Observational, Non-interventional Study for EVICEL ™ Fibrin Sealant (Human) When Used as an Adjunct to Haemostasis in Vascular Surgery

The objective of this non-interventional Post Authorisation Safety Surveillance (PASS) study is to observe the clinical safety performance of EVICEL when used as suture support for haemostasis in vascular surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Memorial Hospital
      • Jacksonville, Florida, United States, 32207
        • Baptist Health Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects requiring elective vascular procedures

Description

Inclusion Criteria:

  • Subjects, 18 years or older, requiring elective, primary or repeat vascular procedures with at least one end-to-side anastomosis to the femoral artery or to an upper extremity artery
  • EVICEL Fibrin Sealant is used as an adjunct to obtain haemostasis at a target anastomosis/es
  • Subjects must be willing to and capable of participating in the study, and provide written informed consent

Exclusion Criteria:

  • Subjects with known intolerance to blood products
  • Subjects unwilling to receive blood products
  • Subjects with any intra-operative findings that may preclude the use of a fibrin sealant to control suture line anastomotic bleeding
  • Subject participating in another study with an investigational (pre-approved) drug or device within 30 days of surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Vascular Surgery Subjects Treated with EVICEL
Biological: EVICEL ™ Fibrin Sealant (Human)
Commercial Evicel
Other Names:
  • Fibrin Sealant (Human)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specific Safety Parameters
Time Frame: Up to 4-weeks post-operatively
  • Incidence of graft occlusion
  • Incidence of adverse events potentially related to non-graft thrombotic events
  • Incidence of bleeding events
Up to 4-weeks post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ethicon, Inc.

Collaborators

OMRIX Biopharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

July 6, 2010

First Submitted That Met QC Criteria

July 6, 2010

First Posted (Estimate)

July 8, 2010

Study Record Updates

Last Update Posted (Estimate)

August 19, 2015

Last Update Submitted That Met QC Criteria

July 22, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 400-08-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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