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

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.

Study Overview

• Status: Completed
• Conditions: Biliary Strictures
• Intervention / Treatment: Device: GORE® VIABIL® Biliary Endoprosthesis

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Ludwigsburg, Germany
    • Klinikum Ludwigsburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: GORE VIABIL® Biliary Endoprosthesis; Placement of GORE VIABIL® Biliary Endoprosthesis to establish duct patency	Device: GORE® VIABIL® Biliary Endoprosthesis; Deployment of GORE® VIABIL® Biliary Endoprosthesis to the area of stricture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safe Stent Removal	The stent removal is considered safe when the Study Device is removed successfully and without SAEs.	Upon Removal

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Device Patency	Primary device patency is defined as the freedom from device occlusion requiring intervention (during the treatment period).	12 Months
Successful Delivery and Deployment	This requires successful delivery and deployment of the device at the intended site.	Upon Implant
Successful Treatment of Benign Stricture Upon Implant	Successful treatment of strictures is defined as stricture resolution upon implant as reported by the PI. For the purpose of this report, we will be referring to this as "stented stricture resolution".	Upon implant
Secondary Patency		12 Months
Viability of Treatment	Treatment is considered viable when the Study Device is removed and the structure is either resolved or improved without the need for re-stenting at the time of Study Device removal.	Upon Removal
Secondary Patency Post Study Device Removal	Secondary patency post study device removal is defined as the absence of stricture recurrence from time of Study Device removal to study completion or lost to follow up. Secondary Patency is also known as Long Term Stricture Resolution.	15 Months
Primary Patency of Treated Stricture	Primary patency of the treated stricture is defined as freedom from stricture intervention due to occlusion following Study Device removal.	15 Months

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates
• Investigators: Principal Investigator: Karel Caca, MD, Klinikum Ludwigsburg

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2011
• Primary Completion (ACTUAL): May 1, 2015
• Study Completion (ACTUAL): May 1, 2015

Study Registration Dates

• First Submitted: February 14, 2011
• First Submitted That Met QC Criteria: April 26, 2011
• First Posted (ESTIMATE): April 27, 2011

Study Record Updates

• Last Update Posted (ACTUAL): April 21, 2021
• Last Update Submitted That Met QC Criteria: March 25, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Biliary Tract Diseases; Bile Duct Diseases; Constriction, Pathologic; Cholestasis
• Other Study ID Numbers: VBR CS 156