Evolution® Biliary Stent System-Fully Covered

Completed · Not applicable

Conditions studied: Carcinomas/Neoplasms

In brief

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.

Key facts

Study ID

NCT02104076

Run by

Cook Group Incorporated

People needed

90

Starts

2014-09-01

Expected to finish

2017-01-04

Last updated by the study team

2017-07-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• < 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

Where it is running

• University of Colorado Hospital — Aurora, Colorado, United States
• Borland-Groover Clinic — Jacksonville, Florida, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Indiana University Hospital — Indianapolis, Indiana, United States
• Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• University of Virginia Health System — Charlottesville, Virginia, United States
• St. Michael's Hospital — Toronto, Ontario, Canada
• Centre Hospitalier de 1'Université — Montreal, Quebec, Canada
• Hôpital Edouard Herriot — Lyon, France
• Hôpital L'Archet 2 — Nice, France
• Erasmus Medish Centrum — Rotterdam, Netherlands

Full record on ClinicalTrials.gov

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