Removable GORE VIABIL® Biliary Endoprosthesis for Treatment of Benign Biliary Strictures
Not Applicable
Completed
- Conditions
- Biliary Strictures
- Interventions
- Device: GORE® VIABIL® Biliary Endoprosthesis
- Registration Number
- NCT01343160
- Lead Sponsor
- W.L.Gore & Associates
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description GORE VIABIL® Biliary Endoprosthesis GORE® VIABIL® Biliary Endoprosthesis Placement of GORE VIABIL® Biliary Endoprosthesis to establish duct patency
- Primary Outcome Measures
Name Time Method Safe Stent Removal Upon Removal The stent removal is considered safe when the Study Device is removed successfully and without SAEs.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Klinikum Ludwigsburg
🇩🇪Ludwigsburg, Germany