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Removable GORE VIABIL® Biliary Endoprosthesis for Treatment of Benign Biliary Strictures | Clinical Trials | Clareo Health

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Removable GORE VIABIL® Biliary Endoprosthesis for Treatment of Benign Biliary Strictures

Multicenter Study of Removable GORE VIABIL® Biliary Endoprosthesis for Treatment of Benign Biliary Strictures

NCT01343160•W.L.Gore & Associates

View on ClinicalTrials.gov

Summary

The purpose of this study is to generate clinical data to support the use of GORE® VIABIL® Biliary Endoprosthesis in the endoscopic and percutaneous treatment of benign biliary strictures.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject is diagnosed with treatable benign biliary stricture which necessitates the need for implantation of a biliary endoprosthesis
•Subject is ≥18 years of age
•Subject is able to comply with study protocol and follow-up requirements
•Written informed consent is obtained using the Investigational Review Board (IRB)/Ethics Committee (EC) approved consent form

Exclusion Criteria

•Subject anatomy ruling out covered self expanding metal stent use (e.g. above hilar region)
•Treatment of stricture would require placement of a covered biliary endoprosthesis within a previously placed bare metal stent
•The subject has malignant biliary disease
•Subject has known pregnancy
•Participated in protocol involving investigational drug or device within 90 days prior to entry into this study

Locations (1)

Klinikum Ludwigsburg

Ludwigsburg, Germany

Key Dates

Start Date

April 1, 2011

Primary Completion Date

May 1, 2015

Completion Date

May 1, 2015

Last Updated

April 21, 2021

Enrollment

ACTUAL participants

Conditions

Biliary Strictures

Interventions

GORE® VIABIL® Biliary Endoprosthesis

DEVICE

Endoscopic Ultrasound-guided Fine-needle Biopsy for Tissue Sampling of Biliary Strictures: a Multicenter Prospective Study

NCT06614452

Biliary Strictures

View study

COMPLETED

Quality Assessment in Endoscopic Retrograde Cholangiopancreatography(ERCP)

NCT02698137

Cholangiopancreatography, Endoscopic RetrogradeCommon Bile Duct Lithiasis+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 21, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Removable GORE VIABIL® Biliary Endoprosthesis for Treatment of Benign Biliary Strictures

Inclusion Criteria

Exclusion Criteria

Endoscopic Ultrasound-guided Fine-needle Biopsy for Tissue Sampling of Biliary Strictures: a Multicenter Prospective Study

Quality Assessment in Endoscopic Retrograde Cholangiopancreatography(ERCP)

Prospective, Multi-Center All-Comer Biliary Canadian WallFlex Registry

Covered Self-expandable Metal Stents for Palliation of Malignant Biliary Strictures: Evaluation of a New Type of Stent