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Evolution® Biliary Stent System-Fully Covered

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02104076
Recruitment Status : Completed
First Posted : April 4, 2014
Last Update Posted : July 5, 2017
Information provided by (Responsible Party):
Cook Group Incorporated

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Carcinomas/Neoplasms Device: Evolution® Biliary Stent-Fully Covered Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation for the Effectiveness of Evolution® Biliary Stent System-Fully Covered
Study Start Date : September 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : January 4, 2017

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

Primary Outcome Measures :
  1. Percentage of patients free from symptomatic recurrent of biliary obstruction requiring reintervention [ Time Frame: 6 months ]
  2. Total Serum Bilirubin ≤ 3.0 mg/dL [ Time Frame: 1 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02104076

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

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Responsible Party: Cook Group Incorporated Identifier: NCT02104076     History of Changes
Other Study ID Numbers: 10-014
First Posted: April 4, 2014    Key Record Dates
Last Update Posted: July 5, 2017
Last Verified: June 2017
Keywords provided by Cook Group Incorporated:
Bile Duct Obstructions
Biliary Stases
Biliary Tract