Biliary StricturesNCT01343160
Removable GORE VIABIL® Biliary Endoprosthesis for Treatment of Benign Biliary Strictures
A study testing GORE® VIABIL® Biliary Endoprosthesis in people with Biliary Strictures, run by W.L.Gore & Associates at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Strictures
- What is being tested?
- GORE® VIABIL® Biliary Endoprosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2011to May 2015
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Biliary Strictures
- Being tested
- GORE® VIABIL® Biliary Endoprosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GORE® VIABIL® Biliary EndoprosthesisDevice
Deployment of GORE® VIABIL® Biliary Endoprosthesis to the area of stricture
| Study group | Role | What they receive |
|---|---|---|
| GORE VIABIL® Biliary Endoprosthesis | Other | Placement of GORE VIABIL® Biliary Endoprosthesis to establish duct patency Receives: Device: GORE® VIABIL® Biliary Endoprosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safe Stent Removal
The stent removal is considered safe when the Study Device is removed successfully and without SAEs.
Measured: Upon Removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Biliary StricturesStudies of the same condition, open and under way.
- More trials run by W.L.Gore & AssociatesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karel Caca, MD, Principal investigator, Klinikum Ludwigsburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01343160
- Sponsor's protocol ID
- VBR CS 156
- Status last verified
- Mar 2021
- First submitted
- 14 Feb 2011
- Last updated
- 21 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No