Evolution® Biliary Stent System-Fully Covered

Carcinomas/Neoplasms Clinical Trial

Official title:

Evaluation for the Effectiveness of Evolution® Biliary Stent System-Fully Covered

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02104076
• Other study ID #: 10-014
• Status: Completed
• Phase: N/A
• First received: April 2, 2014
• Last updated: June 30, 2017
• Start date: September 2014
• Est. completion date: January 4, 2017

Study information

• Verified date: June 2017
• Source: Cook Group Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Evolution® Biliary Stent System-Fully Covered study is a clinical trial approved by the US FDA to evaluate the effectiveness of the Evolution® Biliary Stent System-Fully Covered when used in palliation of malignant neoplasms in the biliary tree.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 4, 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Inoperable malignant neoplasm causing biliary obstruction or stricture that requires a fully covered metal stent

Exclusion Criteria:

• < 18 years of age

• Unwilling or unable to sign and date the informed consent

• Unwilling or unable to comply with the follow-up schedule

• Undergone or is planning to undergo brachytherapy with transpapillary or percutaneous implantation of intracavitary radiation sources

• Participating in another investigational drug or device study in which patient has not completed the follow-up phase for the primary endpoint at least 30 days prior to enrollment

• Endoscopic procedures are contraindicated

• Current anatomy upstream of intended stent placement compromising the flow of bile from the liver such that stent placement may not alleviate the biliary obstruction symptoms

• Presence of a metal biliary stent

• Presence of an esophageal or duodenal stent

• Hypersensitivity/allergy or contraindication to any component of the stent, delivery system, or medication required to complete the procedure,which in the investigator's opinion cannot be adequately premedicated

• Coagulopathy

• Diffuse intrahepatic metastases that involves > 10 % of the liver

• Life expectancy of < 3 months

• Pregnant

• Active alcohol or substance abuse issue

• Jaundice secondary to a cause other than biliary duct obstruction

• Additional endoscopic restrictions as specified in the Clinical Investigation Plan

Related Conditions & MeSH terms

• Carcinomas/Neoplasms

Intervention

Device:
• Evolution® Biliary Stent-Fully Covered
Implantation of the Evolution® Biliary Stent-Fully Covered in the common bile duct utilizing ERCP

Locations

Country	Name	City	State
Canada	Centre Hospitalier de 1'Université	Montréal	Quebec
Canada	St. Michael's Hospital	Toronto	Ontario
France	Hôpital Edouard Herriot	Lyon Cedex 03
France	Hôpital L'Archet 2	Nice Cedex 03
Netherlands	Erasmus Medish Centrum	Rotterdam
United States	University of Colorado Hospital	Aurora	Colorado
United States	University of Virginia Health System	Charlottesville	Virginia
United States	Indiana University Hospital	Indianapolis	Indiana
United States	Borland-Groover Clinic	Jacksonville	Florida
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Moffitt Cancer Center	Tampa	Florida
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Cook Group Incorporated

Countries where clinical trial is conducted

United States,  Canada,  France,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients free from symptomatic recurrent of biliary obstruction requiring reintervention		6 months
Primary	Total Serum Bilirubin = 3.0 mg/dL		1 month