Evolution® Biliary Stent System Clinical Study

Completed

• Conditions: Gastrointestinal Diseases; Neoplasms; Biliary Tract; Biliary Tract Neoplasms; Digestive System Diseases; Stents
• Interventions: Device: Evolution® Biliary Stent - Uncovered

• Registration Number: NCT01962168
• Lead Sponsor: Cook Group Incorporated

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-09
• Study First Submitted QC: 2013-10-11
• Study First Posted: 2013-10-14
• Study Start: 2013-12
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-07
• Last Update Posted: 2015-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Evolution® Biliary Stent - Uncovered	Evolution® Biliary Stent - Uncovered	-

Primary Outcome Measures

Name	Time	Method
Freedom from symptomatic recurrent biliary obstruction requiring reintervention	6 months

Secondary Outcome Measures

Name	Time	Method
Incidence of device-related adverse events	6 months
Technical success	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.
Ease of use	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.

Trial Locations

Locations (9)

The Pancreas and Biliary Center of South Florida; 🇺🇸 Boca Raton, Florida, United States

SUNY at Stony Brook Hospital; 🇺🇸 Stony Brook, New York, United States

Florida Hospital; 🇺🇸 Orlando, Florida, United States

Aurora Saint Luke's Medical Center; 🇺🇸 Milwaukee, Wisconsin, United States

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

Northwest Community Hospital; 🇺🇸 Arlington Heights, Illinois, United States

Borland-Groover Clinic; 🇺🇸 Jacksonville, Florida, United States

University of Massachusetts Medical School; 🇺🇸 Worcester, Massachusetts, United States

Mobile Infirmary Medical Center; 🇺🇸 Mobile, Alabama, United States