Evolution® Biliary Stent System-Fully Covered

Cook Group

Status: Completed

Conditions: Carcinomas/Neoplasms

Treatments: Device: Evolution® Biliary Stent-Fully Covered

Study type: Interventional

Funder types: Industry

Identifiers

NCT02104076

10-014

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

Evolution® Biliary Stent-Fully Covered

Experimental group

Treatment:

Device: Evolution® Biliary Stent-Fully Covered