SuspendedNot Applicable

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

Stopped: The Gore VIABILITY Pivotal Study is being suspended. The suspension is not due to any safety or performance concerns. No sites have been activated and no subjects have been enrolled in the study.

United States133 participantsStarted 2024-02-01

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. A diagnosis of chronic pancreatitis
. Indication for ERCP with FCSEMS placement determined by one or more of the following:
. Presence of a Bismuth type I BBS confirmed by imaging (e.g., cholangiography, Computed Tomography \[CT\], Magnetic Resonance Cholangiopancreatography \[MRCP\], etc.) collected ≤ 60 days prior to the index procedure and an elevation of serum alkaline phosphatase (\>2 times the upper limit of institutional reference range)
. Presence of a symptomatic (e.g., jaundice, cholangitis, and/or choledocholithiasis) Bismuth type I BBS confirmed by imaging (e.g., cholangiography, CT, MRCP, etc.) collected ≤ 60 days prior to the index procedure with an elevation of serum alkaline phosphatase (\>2 times the upper limit of institutional reference range)
. A planned exchange of multiple side-by-side plastic stents (whose combined diameters are ≤ 20 Fr) that were previously placed for management of a Bismuth type I BBS secondary to chronic pancreatitis

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safe stent removal as reported by serious adverse event reporting

Timeframe: At removal (10-12 months)

Trial details

NCT IDNCT05820009

SponsorW.L.Gore & Associates

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-08-01

View on ClinicalTrials.gov More Pancreatitis, Chronic trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. A diagnosis of chronic pancreatitis
. Indication for ERCP with FCSEMS placement determined by one or more of the following:
. Presence of a Bismuth type I BBS confirmed by imaging (e.g., cholangiography, Computed Tomography \[CT\], Magnetic Resonance Cholangiopancreatography \[MRCP\], etc.) collected ≤ 60 days prior to the index procedure and an elevation of serum alkaline phosphatase (\>2 times the upper limit of institutional reference range)
. Presence of a symptomatic (e.g., jaundice, cholangitis, and/or choledocholithiasis) Bismuth type I BBS confirmed by imaging (e.g., cholangiography, CT, MRCP, etc.) collected ≤ 60 days prior to the index procedure with an elevation of serum alkaline phosphatase (\>2 times the upper limit of institutional reference range)
. A planned exchange of multiple side-by-side plastic stents (whose combined diameters are ≤ 20 Fr) that were previously placed for management of a Bismuth type I BBS secondary to chronic pancreatitis

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria