Back to resultsRemovable GORE VIABIL® Biliary Endoprosthesis for Treatment of Benign Biliary Strictures
Primary Purpose
Biliary Strictures
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
GORE® VIABIL® Biliary Endoprosthesis
Sponsored by
About this trial
This is an interventional treatment trial for 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
Sites / Locations
- Klinikum Ludwigsburg
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
GORE VIABIL® Biliary Endoprosthesis
Arm Description
Placement of GORE VIABIL® Biliary Endoprosthesis to establish duct patency
Outcomes
Primary Outcome Measures
Safe Stent Removal
The stent removal is considered safe when the Study Device is removed successfully and without SAEs.
Secondary Outcome Measures
Full Information
NCT ID
NCT01343160
First Posted
February 14, 2011
Last Updated
March 25, 2021
Sponsor
W.L.Gore & Associates
1. Study Identification
Unique Protocol Identification Number
NCT01343160
Brief Title
Removable GORE VIABIL® Biliary Endoprosthesis for Treatment of Benign Biliary Strictures
Official Title
Multicenter Study of Removable GORE VIABIL® Biliary Endoprosthesis for Treatment of Benign Biliary Strictures
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 2011 (Actual)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
W.L.Gore & Associates
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Strictures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GORE VIABIL® Biliary Endoprosthesis
Arm Type
Other
Arm Description
Placement of GORE VIABIL® Biliary Endoprosthesis to establish duct patency
Intervention Type
Device
Intervention Name(s)
GORE® VIABIL® Biliary Endoprosthesis
Intervention Description
Deployment of GORE® VIABIL® Biliary Endoprosthesis to the area of stricture
Primary Outcome Measure Information:
Title
Safe Stent Removal
Description
The stent removal is considered safe when the Study Device is removed successfully and without SAEs.
Time Frame
Upon Removal
Other Pre-specified Outcome Measures:
Title
Primary Device Patency
Description
Primary device patency is defined as the freedom from device occlusion requiring intervention (during the treatment period).
Time Frame
12 Months
Title
Successful Delivery and Deployment
Description
This requires successful delivery and deployment of the device at the intended site.
Time Frame
Upon Implant
Title
Successful Treatment of Benign Stricture Upon Implant
Description
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".
Time Frame
Upon implant
Title
Secondary Patency
Time Frame
12 Months
Title
Viability of Treatment
Description
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.
Time Frame
Upon Removal
Title
Secondary Patency Post Study Device Removal
Description
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.
Time Frame
15 Months
Title
Primary Patency of Treated Stricture
Description
Primary patency of the treated stricture is defined as freedom from stricture intervention due to occlusion following Study Device removal.
Time Frame
15 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karel Caca, MD
Organizational Affiliation
Klinikum Ludwigsburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum Ludwigsburg
City
Ludwigsburg
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Removable GORE VIABIL® Biliary Endoprosthesis for Treatment of Benign Biliary Strictures
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