Evolution® Biliary Stent System Clinical Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01962168
First received: October 9, 2013
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Biliary Tract Neoplasms
Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Biliary Tract
Stents
Device: Evolution® Biliary Stent - Uncovered

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Palliation of Biliary Neoplasms With the Cook Evolution® Biliary Stent System

Resource links provided by NLM:


Further study details as provided by Cook:

Primary Outcome Measures:
  • Freedom from symptomatic recurrent biliary obstruction requiring reintervention [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Technical success [ Time Frame: Immediately following completion of the stent placement procedure ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
  • Ease of use [ Time Frame: Immediately following completion of the stent placement procedure ] [ Designated as safety issue: No ]
    Ease of use will be evaluated on a five point scale ranging from very easy to very difficult.


Enrollment: 113
Study Start Date: December 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Evolution® Biliary Stent - Uncovered Device: Evolution® Biliary Stent - Uncovered
Commercially available device

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01962168

Locations
United States, Alabama
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36607
United States, Florida
The Pancreas and Biliary Center of South Florida
Boca Raton, Florida, United States, 33486
Borland-Groover Clinic
Jacksonville, Florida, United States, 32256
Florida Hospital
Orlando, Florida, United States, 32803
United States, Illinois
Northwest Community Hospital
Arlington Heights, Illinois, United States, 60005
United States, Massachusetts
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
United States, New York
SUNY at Stony Brook Hospital
Stony Brook, New York, United States, 11794
United States, Wisconsin
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Canada, Quebec
Centre Hospitalier de l' Universite de Montreal (CHUM)
Montreal, Quebec, Canada, H2X 3J4
Sponsors and Collaborators
Cook
Investigators
Principal Investigator: Christopher Lawrence Summerville GI & Advanced Endoscopy
  More Information

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT01962168     History of Changes
Other Study ID Numbers: 12-009
Study First Received: October 9, 2013
Last Updated: October 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Cook:
Biliary Tract Neoplasms
Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Biliary Tract
Stents

Additional relevant MeSH terms:
Biliary Tract Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Neoplasms
Biliary Tract Diseases
Digestive System Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 20, 2014