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

NCT05820009 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2024-01-29

No results posted yet for this study

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).

Conditions

  • Pancreatitis, Chronic
  • Stricture; Bile Duct

Interventions

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

Sponsors & Collaborators

  • W.L.Gore & Associates

    lead INDUSTRY

Principal Investigators

  • Todd Baron, MD · University of North Carolina Medical Center

  • Shayan Irani, MD · Virginia Mason Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2026-08-01
Completion
2028-08-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05820009 on ClinicalTrials.gov