Evolution® Biliary Stent System Clinical Study

April 7, 2015 updated by: Cook Group Incorporated

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

113

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2X 3J4
        • Centre Hospitalier de l' Universite de Montreal (CHUM)
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36607
        • Mobile Infirmary Medical Center
    • Florida
      • Boca Raton, Florida, United States, 33486
        • The Pancreas and Biliary Center of South Florida
      • Jacksonville, Florida, United States, 32256
        • Borland-Groover Clinic
      • Orlando, Florida, United States, 32803
        • Florida Hospital
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Northwest Community Hospital
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Medical School
    • New York
      • Stony Brook, New York, United States, 11794
        • SUNY at Stony Brook Hospital
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora Saint Luke's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Candidates for biliary stent placement based on institutional guidelines and product IFU.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Evolution® Biliary Stent - Uncovered
Device: Evolution® Biliary Stent - Uncovered
Commercially available device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Freedom from symptomatic recurrent biliary obstruction requiring reintervention
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately following completion of the stent placement procedure
Incidence of device-related adverse events
Time Frame: 6 months
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.
Immediately following completion of the stent placement procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook Group Incorporated

Investigators

  • Principal Investigator: Christopher Lawrence, Summerville GI & Advanced Endoscopy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

October 9, 2013

First Submitted That Met QC Criteria

October 11, 2013

First Posted (Estimate)

October 14, 2013

Study Record Updates

Last Update Posted (Estimate)

April 8, 2015

Last Update Submitted That Met QC Criteria

April 7, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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