N/A
N=36
Removable GORE VIABIL® Biliary Endoprosthesis for Treatment of Benign Biliary Strictures
Biliary Strictures
Bottom Line
View on ClinicalTrials.gov: NCT01343160 ↗Enrolled (actual)
36
Serious AEs
52.8%
Results posted
Apr 2021
Primary outcome: Primary: Safe Stent Removal — 33 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- GORE® VIABIL® Biliary Endoprosthesis (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- W.L.Gore & Associates
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safe Stent Removal |
33 | — |
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 Criteria
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
Data sourced from ClinicalTrials.gov (NCT01343160). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.