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Completed

NCT Number: NCT02104076

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.

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Key information

Conditions

Carcinomas/Neoplasms Bile Duct Diseases Biliary Tract Diseases Carcinoma Cholestasis Digestive System Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Michael's Hospital, Toronto, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evolution® Biliary Stent-Fully Covered

Device

Implantation of the Evolution® Biliary Stent-Fully Covered in the common bile duct utilizing ERCP

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Apr 4, 2014
Registry last updated
Jul 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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