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GORE® VIABIL® Biliary Endoprosthesis in the Treatment of Benign Biliary Strictures Secondary to Chronic Pancreatitis — VIABILITY  

Pancreatitis, Chronic Clinical Trial

Official title:
Evaluation of the GORE® VIABIL® Biliary Endoprosthesis in the Treatment of Benign Biliary Strictures Secondary to Chronic Pancreatitis

Clinical Trial Summary

This study will evaluate the safety and effectiveness of the GORE® VIABIL® Biliary Endoprosthesis in the treatment of benign biliary strictures secondary to Chronic Pancreatitis (CP).

Clinical Trial Description

A maximum of 15 clinical investigative sites across the U.S. will participate in this study. One hundred and thirty-three subjects are intended to be implanted with the GORE® VIABIL® Biliary Endoprosthesis in this study. Subjects will be evaluated at the time of device placement and will have follow-up visits at 1 week and 1, 3, 6, and 9 months during indwell; subjects will have the device removed at 10-12 months and have post removal follow-up visits at 1 week and 1, 3, 6, 12 and 24 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05820009
Study type Interventional
Source W.L.Gore & Associates
Contact
Status Suspended
Phase N/A
Start date February 1, 2024
Completion date August 1, 2028
View Details
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