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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01962168
Other study ID # 12-009
Secondary ID
Status Completed
Phase N/A
First received October 9, 2013
Last updated April 7, 2015
Start date December 2013
Est. completion date March 2015

Study information

Verified date April 2015
Source Cook
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 113
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Device:
Evolution® Biliary Stent - Uncovered
Commercially available device

Locations

Country Name City State
Canada Centre Hospitalier de l' Universite de Montreal (CHUM) Montreal Quebec
United States Northwest Community Hospital Arlington Heights Illinois
United States The Pancreas and Biliary Center of South Florida Boca Raton Florida
United States Borland-Groover Clinic Jacksonville Florida
United States Aurora Saint Luke's Medical Center Milwaukee Wisconsin
United States Mobile Infirmary Medical Center Mobile Alabama
United States Florida Hospital Orlando Florida
United States SUNY at Stony Brook Hospital Stony Brook New York
United States University of Massachusetts Medical School Worcester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Cook

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Freedom from symptomatic recurrent biliary obstruction requiring reintervention 6 months No
Secondary Technical success 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 No
Secondary Incidence of device-related adverse events 6 months Yes
Secondary Ease of use 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 No
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