Evolution® Biliary Stent System Clinical Study

The Evolution® Biliary Stent System Clinical Study is a clinical trial on a commercially available device to gather physician experience with the Cook Evolution® Biliary Stent System for the palliation of cancer in the biliary tree. Patients will be treated as per usual medical practices.

Completed

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Key information

Conditions

Biliary Tract Neoplasms Biliary Tract Biliary Tract Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Neoplasms Neoplasms by Site Stents

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier de l' Universite de Montreal (CHUM), Montreal, Quebec, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patient is considered a candidate for stent placement based on institutional guidelines and product IFU.

Exclusion criteria

Patient is less than 18 years of age.
Patient is unable or unwilling to provide written informed consent.
Patient is unable or unwilling to comply with the follow-up schedule.

Treatment and study plan

Evolution® Biliary Stent - Uncovered

Device

Commercially available device

Primary outcomes

Freedom from symptomatic recurrent biliary obstruction requiring reintervention

Time frame: 6 months

Secondary outcomes

Technical success

Time frame: Immediately following completion of the stent placement procedure

Technical success is defined as a stent successfully delivered and placed at its intended location at the end of the procedure.
Incidence of device-related adverse events

Time frame: 6 months
Ease of use

Time frame: Immediately following completion of the stent placement procedure

Ease of use will be evaluated on a five point scale ranging from very easy to very difficult.

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Registry information

Official study title

Palliation of Biliary Neoplasms With the Cook Evolution® Biliary Stent System

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Oct 14, 2013
Registry last updated: Apr 8, 2015

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.

Published trials that share one or more normalized conditions with this study.

Completed