Evolution® Biliary Stent System-Fully Covered

June 30, 2017 updated by: Cook Group Incorporated

Evaluation for the Effectiveness of Evolution® Biliary Stent System-Fully Covered

The Evolution® Biliary Stent System-Fully Covered study is a clinical trial approved by the US FDA to evaluate the effectiveness of the Evolution® Biliary Stent System-Fully Covered when used in palliation of malignant neoplasms in the biliary tree.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital
    • Quebec
      • Montréal, Quebec, Canada, H2W 1T8
        • Centre Hospitalier de 1'Université
  • France
      • Lyon Cedex 03, France, 69437
        • Hôpital Edouard Herriot
      • Nice Cedex 03, France, 23079
        • Hopital L'Archet 2
  • Netherlands
      • Rotterdam, Netherlands, 3015
        • Erasmus Medish Centrum
  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Borland-Groover Clinic
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Hospital
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908-0908
        • University of Virginia Health System

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

Description

Inclusion Criteria:

  • Inoperable malignant neoplasm causing biliary obstruction or stricture that requires a fully covered metal stent

Exclusion Criteria:

  • < 18 years of age
  • Unwilling or unable to sign and date the informed consent
  • Unwilling or unable to comply with the follow-up schedule
  • Undergone or is planning to undergo brachytherapy with transpapillary or percutaneous implantation of intracavitary radiation sources
  • Participating in another investigational drug or device study in which patient has not completed the follow-up phase for the primary endpoint at least 30 days prior to enrollment
  • Endoscopic procedures are contraindicated
  • Current anatomy upstream of intended stent placement compromising the flow of bile from the liver such that stent placement may not alleviate the biliary obstruction symptoms
  • Presence of a metal biliary stent
  • Presence of an esophageal or duodenal stent
  • Hypersensitivity/allergy or contraindication to any component of the stent, delivery system, or medication required to complete the procedure,which in the investigator's opinion cannot be adequately premedicated
  • Coagulopathy
  • Diffuse intrahepatic metastases that involves > 10 % of the liver
  • Life expectancy of < 3 months
  • Pregnant
  • Active alcohol or substance abuse issue
  • Jaundice secondary to a cause other than biliary duct obstruction
  • Additional endoscopic restrictions as specified in the Clinical Investigation Plan

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

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Evolution® Biliary Stent-Fully Covered
Device: Evolution® Biliary Stent-Fully Covered
Implantation of the Evolution® Biliary Stent-Fully Covered in the common bile duct utilizing ERCP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients free from symptomatic recurrent of biliary obstruction requiring reintervention
Time Frame: 6 months
6 months
Total Serum Bilirubin ≤ 3.0 mg/dL
Time Frame: 1 month
1 month

Collaborators and Investigators

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

Sponsor

Cook Group Incorporated

Investigators

  • Principal Investigator: Raj Shah, M.D., University of Colorado, Denver
  • Principal Investigator: Marco Bruno, M.D., Erasmus Medish Centrum

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

September 1, 2014

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

January 4, 2017

Study Registration Dates

First Submitted

April 2, 2014

First Submitted That Met QC Criteria

April 2, 2014

First Posted (Estimate)

April 4, 2014

Study Record Updates

Last Update Posted (Actual)

July 5, 2017

Last Update Submitted That Met QC Criteria

June 30, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 10-014

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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