Evolution® Biliary Stent System Clinical Study

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01962168
• Other study ID #: 12-009
• 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

Related Conditions & MeSH terms

• Biliary Tract
• Biliary Tract Neoplasms
• Digestive System Diseases
• Gastrointestinal Diseases
• Neoplasms
• Stents

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