Evolution® Biliary Stent System-Fully Covered

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2017-01-04

Brief Summary

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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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Detailed Description

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Conditions

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Carcinomas/Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Evolution® Biliary Stent-Fully Covered

Group Type EXPERIMENTAL

Evolution® Biliary Stent-Fully Covered

Intervention Type DEVICE

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

Interventions

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Evolution® Biliary Stent-Fully Covered

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No