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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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
Are there results?: Yes, posted in the registrySummary in the doctors' view

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.

Germany1 site

Klinikum Ludwigsburg
Ludwigsburg

Other trials in Germany

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 groups in NCT01343160
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.

Apr 2011May 2015

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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The HANAROSTENT® Multi-Hole™ Biliary Stent is Indicated for Use in the Palliative Treatment of Biliary Strictures Produced by Malignant Neoplasms and the Study is to Demonstrate Clinical Safety and Performance of the Multi-Hole™ Stent for the Palliative Treatment of Malignant Biliary Obstruction.
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All Biliary Strictures trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter Study of Removable GORE VIABIL® Biliary Endoprosthesis for Treatment of Benign Biliary Strictures
ClinicalTrials.gov ID: NCT01343160
Acronym / sponsor ID: VBR CS 156
Conditions: Biliary Strictures
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
Study start: Apr 2011 (actual)
Primary completion: May 2015 (actual)
Study completion: May 2015 (actual)
First posted: 27 Apr 2011 (estimated)
Results: Posted 21 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
GORE VIABIL® Biliary Endoprosthesis	Other	Device: GORE® VIABIL® Biliary EndoprosthesisPlacement of GORE VIABIL® Biliary Endoprosthesis to establish duct patency

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GORE® VIABIL® Biliary EndoprosthesisDeployment of GORE® VIABIL® Biliary Endoprosthesis to the area of stricture	Device	GORE VIABIL® Biliary Endoprosthesis

Primary outcome

Safe Stent Removal
Time frame: Upon Removal
The stent removal is considered safe when the Study Device is removed successfully and without SAEs.

Results and safety

Results posted to the registry on 21 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GORE VIABIL® Biliary Endoprosthesis	36	31

Primary outcome: Safe Stent Removal

Time frame: Upon Removal. Count of participants. Unit: Participants

Measure	GORE VIABIL n = 33
Value	33

Population analysed: Subjects with stent removal data available

Adverse events

Time frame: Adverse events were collected for patients upto 12 Months of treatment period with the stent and upto 15 Months of post stent removal. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GORE VIABIL	19 of 36 (52.8%)	6 of 36 (16.7%)	2 of 36

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Biliary Strictures

RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Endoscopic Ultrasound Guided Hepaticogastrostomy With or Without Antegrade Stenting for Palliation of Malignant Distal Biliary Obstruction: Randomized Controlled Trial
Malignant Biliary Obstruction, Malignant Biliary Stricture
Not yet recruiting
The HANAROSTENT® Multi-Hole™ Biliary Stent is Indicated for Use in the Palliative Treatment of Biliary Strictures Produced by Malignant Neoplasms and the Study is to Demonstrate Clinical Safety and Performance of the Multi-Hole™ Stent for the Palliative Treatment of Malignant Biliary Obstruction.
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RecruitingPhase 2
Pharmacologic Approaches to Preventing Primary Sclerosing Cholangitis Recurrence After Liver Transplantation
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Recruiting
UNITY-B A Prospective, Multicentric, Single-arm Study to Evaluate the Safety and Efficacy of the UNITY-B Biodegradable Balloon-Expandable Biliary Stent System in Subjects With Biliary Strictures
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Karel Caca, MD principal investigator

Klinikum Ludwigsburg

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing GORE® VIABIL® Biliary Endoprosthesis in people with Biliary Strictures, run by W.L.Gore & Associates at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safe Stent Removal (time frame: Upon Removal). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01343160.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2021.