NCT05820009

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

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

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 133 (estimated)
• Sponsor: W.L.Gore & Associates · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Pancreatitis, Chronic
• Stricture; Bile Duct

Interventions

Type	Name	Description
DEVICE	GORE® VIABIL® Biliary Endoprosthesis	Endoscopic treatment of benign biliary stricture secondary to Chronic Pancreatitis with the GORE® VIABIL® Biliary Endoprosthesis.
DEVICE	GORE® VIABIL® Short Wire Biliary Endoprosthesis	Endoscopic treatment of benign biliary stricture secondary to Chronic Pancreatitis with GORE® VIABIL® Short Wire Biliary Endoprosthesis

Timeline

• Start date: 2024-02-01
• Primary completion: 2026-08-01
• Completion: 2028-08-01
• First posted: 2023-04-19
• Last updated: 2024-01-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study