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

Not Applicable

Suspended

• Conditions: Stricture; Bile Duct; Pancreatitis, Chronic
• Interventions: Device: GORE® VIABIL® Biliary Endoprosthesis; Device: GORE® VIABIL® Short Wire Biliary Endoprosthesis

• Registration Number: NCT05820009
• Lead Sponsor: W.L.Gore & Associates

Brief 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.

Study Timeline

• Study First Submitted: 2023-03-16
• Study First Submitted QC: 2023-04-05
• Study First Posted: 2023-04-19
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-25
• Last Update Posted: 2024-01-29
• Study Start: 2024-02-01
• Primary Completion: 2026-08-01
• Study Completion: 2028-08-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 133

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GORE® VIABIL® Biliary Endoprosthesis	GORE® VIABIL® Biliary Endoprosthesis	GORE® VIABIL® Biliary Endoprosthesis
GORE® VIABIL® Biliary Endoprosthesis	GORE® VIABIL® Short Wire Biliary Endoprosthesis	GORE® VIABIL® Biliary Endoprosthesis

Primary Outcome Measures

Name	Time	Method
Safe stent removal as reported by serious adverse event reporting	At removal (10-12 months)	Ability to remove the Study Device endoscopically without stent removal-related serious adverse events (SAEs) as assessed from the time of Study Device removal to one month (30 days) post-Study Device removal.

Secondary Outcome Measures

Name	Time	Method
Placement success as determined by imaging	Day 0	Ability to deploy the Study Device in a satisfactory position across the biliary stricture.
Removal success as determined by imaging	At removal (10-12 months)	Defined as either ability to remove the Study Device endoscopically at scheduled Study Device removal without stent removal-related SAEs or spontaneous Study Device passage without the need for immediate re-stenting
Stricture resolution at stent removal as determined by imaging	At removal (10-12 months)	Defined as freedom from recurrent stent placement at the end of indwell
Stent functionality as determined by adverse event reporting	During indwell up to 12 months	Defined as freedom from Study Device-related reintervention during intended indwell
Migration as determined by imaging	During indwell up to 12 months	Defined as movement of the Study Device such that the Study Device is no longer in a satisfactory position across the biliary stricture during intended indwell.
Stricture recurrence as determined by adverse event reporting	From removal up to 24 months	Defined as any biliary stricture-related re-intervention from the removal procedure through 2 years post-Study Device removal.
Device- or procedure-related SAEs as determined by serious adverse event reporting	Day 0-13 months (including through 30 days post-removal)	Defined as Study Device- or procedure-related SAEs that occur during placement, indwell, or removal (including through 30 days post-removal).
Liver Function as determined by alkaline phosphatase, alanine aminotransferase, and aspartate aminotransferase levels	Baseline, indwell follow-up visits (up to 12 months), at removal (10-12 months), and post-removal follow up visits (up to 24 months)	Including alkaline phosphatase (ALP, U/L), alanine aminotransferase (ALT, U/L), aspartate aminotransferase (AST, U/L) levels
Liver Function as determined by direct bilirubin, and total bilirubin	Baseline, indwell follow-up visits (up to 12 months), at removal (10-12 months), and post-removal follow up visits (up to 24 months)	Including direct bilirubin (mg/dL), and total bilirubin (mg/dL) levels

Trial Locations

Locations (2)

UNC School of Medicine; 🇺🇸 Chapel Hill, North Carolina, United States

Virginia Mason Medical Center; 🇺🇸 Seattle, Washington, United States