Pancreatitis, ChronicVIABILITYNCT05820009
GORE® VIABIL® Biliary Endoprosthesis in the Treatment of Benign Biliary Strictures Secondary to Chronic Pancreatitis
A study testing GORE® VIABIL® Biliary Endoprosthesis and GORE® VIABIL® Short Wire Biliary Endoprosthesis in people with Pancreatitis, Chronic and Stricture; Bile Duct, run by W.L.Gore & Associates at 2 sites in United States.
Trial summary
This study will evaluate the safety and effectiveness of the GORE® VIABIL® Biliary Endoprosthesis in the treatment of benign biliary strictures secondary to Chronic Pancreatitis (CP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatitis, Chronic, Stricture; Bile Duct
- What is being tested?
- GORE® VIABIL® Biliary Endoprosthesis and GORE® VIABIL® Short Wire Biliary Endoprosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2024to 1 Aug 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- A diagnosis of chronic pancreatitis
- Indication for ERCP with FCSEMS placement determined by one or more of the following:
- Presence of a Bismuth type I BBS confirmed by imaging (e.g., cholangiography, Computed Tomography [CT], Magnetic Resonance Cholangiopancreatography [MRCP], etc.) collected ≤ 60 days prior to the index procedure and an elevation of serum alkaline phosphatase (>2 times the upper limit of institutional reference range)
- Presence of a symptomatic (e.g., jaundice, cholangitis, and/or choledocholithiasis) Bismuth type I BBS confirmed by imaging (e.g., cholangiography, CT, MRCP, etc.) collected ≤ 60 days prior to the index procedure with an elevation of serum alkaline phosphatase (>2 times the upper limit of institutional reference range)
- A planned exchange of multiple side-by-side plastic stents (whose combined diameters are ≤ 20 Fr) that were previously placed for management of a Bismuth type I BBS secondary to chronic pancreatitis
- Underlying stricture malignancy has been reasonably excluded (e.g., by any of the following techniques - biopsy, Endoscopic Ultrasound [EUS], Computed Tomography [CT], or Magnetic Resonance Imaging [MRI] with or without Magnetic Resonance Cholangiopancreatography [MRCP]) ≤ 60 days prior to index procedure
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- ≥ 18 years old at the time of informed consent signature
- Male, infertile female, or woman of childbearing potential with a negative beta Human Chorionic Gonadotropin (hCG) pregnancy test within 7 days of the index procedure
- Able and willing to provide written informed consent (or has a Legally Authorized Representative) to participate in the study prior to any study procedures
- Willing and able to comply with the study procedures and follow-up requirements
Who cannot join
- Concurrent participation in another interventional study that involves an investigational product being introduced to the body
- A contraindication for endoscopic techniques
- Life expectancy < 2 years
- A history of malignant biliary or malignant pancreatic disease
- Prior or existing biliary self-expanding metal stent (SEMS)
- Prior or planned exchange of multiple side-by-side plastic stents whose combined diameters are greater than 20 Fr
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- Development of obstructive biliary symptoms associated with a present attack of acute pancreatitis
- Any biliary stricture etiology other than chronic pancreatitis
- Other therapeutic endoscopic procedures performed during the index or removal procedure that are not associated with bile duct stricture secondary to Chronic Pancreatitis including but not limited to planned Fine Needle Aspiration (FNA) or Fine Needle Biopsy (FNB) of the pancreas
- Concomitant Bismuth type II-IV stricture
- Inability for the guidewire to traverse the papillae and the stricture (e.g., as a result of surgically altered anatomy)
- Inability to pass the endoscope to the papillae without the need for mechanical dilation
- Known bile duct fistula or leak
- Biliary stricture length > 100 mm (10 cm)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UNC School of Medicine
Chapel Hill, North Carolina, 27599
Virginia Mason Medical Center
Seattle, Washington, 98101
About this study
Official title: Evaluation of the GORE® VIABIL® Biliary Endoprosthesis in the Treatment of Benign Biliary Strictures Secondary to Chronic Pancreatitis
This study will evaluate the safety and effectiveness of the GORE® VIABIL® Biliary Endoprosthesis in the treatment of benign biliary strictures secondary to Chronic Pancreatitis (CP).
Read the detailed description
A maximum of 15 clinical investigative sites across the U.S. will participate in this study. One hundred and thirty-three subjects are intended to be implanted with the GORE® VIABIL® Biliary Endoprosthesis in this study. Subjects will be evaluated at the time of device placement and will have follow-up visits at 1 week and 1, 3, 6, and 9 months during indwell; subjects will have the device removed at 10-12 months and have post removal follow-up visits at 1 week and 1, 3, 6, 12 and 24 months.
- Conditions
- Pancreatitis, Chronic, Stricture; Bile Duct
- Being tested
- GORE® VIABIL® Biliary Endoprosthesis, GORE® VIABIL® Short Wire Biliary Endoprosthesis
- Keywords
- Benign Bile Duct Stricture
- Medical subject headings
- Pancreatitis, Chronic, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GORE® VIABIL® Biliary EndoprosthesisDevice
Endoscopic treatment of benign biliary stricture secondary to Chronic Pancreatitis with the GORE® VIABIL® Biliary Endoprosthesis.
GORE® VIABIL® Short Wire Biliary EndoprosthesisDevice
Endoscopic treatment of benign biliary stricture secondary to Chronic Pancreatitis with GORE® VIABIL® Short Wire Biliary Endoprosthesis
| Study group | Role | What they receive |
|---|---|---|
| GORE® VIABIL® Biliary Endoprosthesis | Experimental | GORE® VIABIL® Biliary Endoprosthesis Receives: Device: GORE® VIABIL® Biliary Endoprosthesis; Device: GORE® VIABIL® Short Wire Biliary Endoprosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safe stent removal as reported by serious adverse event reporting
Ability to remove the Study Device endoscopically without stent removal-related serious adverse events (SAEs) as assessed from the time of Study Device removal to one month (30 days) post-Study Device removal.
Measured: At removal (10-12 months)
Secondary outcomes (9)
Placement success as determined by imaging
Ability to deploy the Study Device in a satisfactory position across the biliary stricture.
Measured: Day 0
Stent functionality as determined by adverse event reporting
Defined as freedom from Study Device-related reintervention during intended indwell
Measured: During indwell up to 12 months
Migration as determined by imaging
Defined as movement of the Study Device such that the Study Device is no longer in a satisfactory position across the biliary stricture during intended indwell.
Measured: During indwell up to 12 months
Removal success as determined by imaging
Defined as either ability to remove the Study Device endoscopically at scheduled Study Device removal without stent removal-related SAEs or spontaneous Study Device passage without the need for immediate re-stenting
Measured: At removal (10-12 months)
Stricture resolution at stent removal as determined by imaging
Defined as freedom from recurrent stent placement at the end of indwell
Measured: At removal (10-12 months)
Stricture recurrence as determined by adverse event reporting
Defined as any biliary stricture-related re-intervention from the removal procedure through 2 years post-Study Device removal.
Measured: From removal up to 24 months
Device- or procedure-related SAEs as determined by serious adverse event reporting
Defined as Study Device- or procedure-related SAEs that occur during placement, indwell, or removal (including through 30 days post-removal).
Measured: Day 0-13 months (including through 30 days post-removal)
Liver Function as determined by alkaline phosphatase, alanine aminotransferase, and aspartate aminotransferase levels
Including alkaline phosphatase (ALP, U/L), alanine aminotransferase (ALT, U/L), aspartate aminotransferase (AST, U/L) levels
Measured: Baseline, indwell follow-up visits (up to 12 months), at removal (10-12 months), and post-removal follow up visits (up to 24 months)
Liver Function as determined by direct bilirubin, and total bilirubin
Including direct bilirubin (mg/dL), and total bilirubin (mg/dL) levels
Measured: Baseline, indwell follow-up visits (up to 12 months), at removal (10-12 months), and post-removal follow up visits (up to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start1 Feb 2024 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2028 (estimated)
Why it stopped: The Gore VIABILITY Pivotal Study is being suspended. The suspension is not due to any safety or performance concerns. No sites have been activated and no subjects have been enrolled in the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatitis, ChronicStudies 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
- 133 participants (estimated)
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Todd Baron, MD, Principal investigator, University of North Carolina Medical CenterShayan Irani, MD, Principal investigator, Virginia Mason Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820009
- Sponsor's protocol ID
- VBL 22-01
- Acronym
- VIABILITY
- Status last verified
- Jan 2024
- First submitted
- 16 Mar 2023
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the GORE® VIABIL® Biliary Endoprosthesis in the Treatment of Benign Biliary Strictures Secondary to Chronic Pancreatitis
- ClinicalTrials.gov ID
- NCT05820009
- Acronym / sponsor ID
- VIABILITY / VBL 22-01
- Conditions
- Pancreatitis, Chronic, Stricture; Bile Duct
- Keywords
- Benign Bile Duct Stricture
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The Gore VIABILITY Pivotal Study is being suspended. The suspension is not due to any safety or performance concerns. No sites have been activated and no subjects have been enrolled in the study.
- Enrolment
- 133 participants (estimated)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and effectiveness of the GORE® VIABIL® Biliary Endoprosthesis in the treatment of benign biliary strictures secondary to Chronic Pancreatitis (CP).
Detailed description
A maximum of 15 clinical investigative sites across the U.S. will participate in this study. One hundred and thirty-three subjects are intended to be implanted with the GORE® VIABIL® Biliary Endoprosthesis in this study. Subjects will be evaluated at the time of device placement and will have follow-up visits at 1 week and 1, 3, 6, and 9 months during indwell; subjects will have the device removed at 10-12 months and have post removal follow-up visits at 1 week and 1, 3, 6, 12 and 24 months.
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 | Experimental | Device: GORE® VIABIL® Biliary Endoprosthesis, Device: GORE® VIABIL® Short Wire Biliary EndoprosthesisGORE® VIABIL® Biliary Endoprosthesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- A diagnosis of chronic pancreatitis
- Indication for ERCP with FCSEMS placement determined by one or more of the following:
- Underlying stricture malignancy has been reasonably excluded (e.g., by any of the following techniques - biopsy, Endoscopic Ultrasound [EUS], Computed Tomography [CT], or Magnetic Resonance Imaging [MRI] with or without Magnetic Resonance Cholangiopancreatography [MRCP]) ≤ 60 days prior to index procedure
- ≥ 18 years old at the time of informed consent signature
- Male, infertile female, or woman of childbearing potential with a negative beta Human Chorionic Gonadotropin (hCG) pregnancy test within 7 days of the index procedure
Key exclusion criteria (14 listed)
- Concurrent participation in another interventional study that involves an investigational product being introduced to the body
- A contraindication for endoscopic techniques
- Life expectancy < 2 years
- A history of malignant biliary or malignant pancreatic disease
- Prior or existing biliary self-expanding metal stent (SEMS)
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 EndoprosthesisEndoscopic treatment of benign biliary stricture secondary to Chronic Pancreatitis with the GORE® VIABIL® Biliary Endoprosthesis. | Device | GORE® VIABIL® Biliary Endoprosthesis |
| GORE® VIABIL® Short Wire Biliary EndoprosthesisEndoscopic treatment of benign biliary stricture secondary to Chronic Pancreatitis with GORE® VIABIL® Short Wire Biliary Endoprosthesis | Device | GORE® VIABIL® Biliary Endoprosthesis |
Primary outcome
Safe stent removal as reported by serious adverse event reporting
Time frame: At removal (10-12 months)
Ability to remove the Study Device endoscopically without stent removal-related serious adverse events (SAEs) as assessed from the time of Study Device removal to one month (30 days) post-Study Device removal.
9 secondary outcomes
Placement success as determined by imaging
Time frame: Day 0
Stent functionality as determined by adverse event reporting
Time frame: During indwell up to 12 months
Migration as determined by imaging
Time frame: During indwell up to 12 months
Removal success as determined by imaging
Time frame: At removal (10-12 months)
Stricture resolution at stent removal as determined by imaging
Time frame: At removal (10-12 months)
Stricture recurrence as determined by adverse event reporting
Time frame: From removal up to 24 months
Device- or procedure-related SAEs as determined by serious adverse event reporting
Time frame: Day 0-13 months (including through 30 days post-removal)
Liver Function as determined by alkaline phosphatase, alanine aminotransferase, and aspartate aminotransferase levels
Time frame: Baseline, indwell follow-up visits (up to 12 months), at removal (10-12 months), and post-removal follow up visits (up to 24 months)
Liver Function as determined by direct bilirubin, and total bilirubin
Time frame: Baseline, indwell follow-up visits (up to 12 months), at removal (10-12 months), and post-removal follow up visits (up to 24 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Todd Baron, MD principal investigator
University of North Carolina Medical Center
Shayan Irani, MD principal investigator
Virginia Mason Medical Center
2 sites 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 and GORE® VIABIL® Short Wire Biliary Endoprosthesis in people with Pancreatitis, Chronic and Stricture; Bile Duct, run by W.L.Gore & Associates at 2 sites in United States.
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 10 inclusion and 14 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: paused, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Results are not available in the source record.
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 as reported by serious adverse event reporting (time frame: At removal (10-12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2024.