Evolution® Biliary Stent System Clinical Study

Cook Group

Status: Completed

Conditions: Biliary Tract; Gastrointestinal Diseases; Neoplasms; Biliary Tract Neoplasms; Digestive System Diseases; Stents

Treatments: Device: Evolution® Biliary Stent - Uncovered

Study type: Observational

Funder types: Industry

Identifiers

NCT01962168

12-009

Details and patient eligibility

About

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.

Enrollment: 113 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

113 participants in 1 patient group

Evolution® Biliary Stent - Uncovered

Treatment:

Device: Evolution® Biliary Stent - Uncovered