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
1 other identifier
interventional
43
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedFirst Posted
Study publicly available on registry
April 27, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedResults Posted
Study results publicly available
April 21, 2021
CompletedApril 21, 2021
March 1, 2021
4.1 years
February 14, 2011
March 25, 2021
March 25, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Safe Stent Removal
The stent removal is considered safe when the Study Device is removed successfully and without SAEs.
Upon Removal
Other Outcomes (7)
Primary Device Patency
12 Months
Successful Delivery and Deployment
Upon Implant
Successful Treatment of Benign Stricture Upon Implant
Upon implant
- +4 more other outcomes
Study Arms (1)
GORE VIABIL® Biliary Endoprosthesis
OTHERPlacement of GORE VIABIL® Biliary Endoprosthesis to establish duct patency
Interventions
Deployment of GORE® VIABIL® Biliary Endoprosthesis to the area of stricture
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Klinikum Ludwigsburg
Ludwigsburg, Germany
Results Point of Contact
- Title
- Rizwan Afzal
- Organization
- W.L. Gore & Associates
Study Officials
- PRINCIPAL INVESTIGATOR
Karel Caca, MD
Klinikum Ludwigsburg
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2011
First Posted
April 27, 2011
Study Start
April 1, 2011
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
April 21, 2021
Results First Posted
April 21, 2021
Record last verified: 2021-03