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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01014390
Registration number
NCT01014390
Ethics application status
Date submitted
13/11/2009
Date registered
17/11/2009
Date last updated
19/02/2020
Titles & IDs
Public title
WallFlex Biliary Fully Covered (FC) Benign Stricture Study
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Scientific title
A Multi-Center, Prospective Study of the WallFlex Biliary RX Fully Covered Stent for the Treatment of Benign Biliary Strictures
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Secondary ID [1]
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CDM 00027550
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Biliary Stricture
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - WallFlex Biliary RX Fully Covered Stent System
Experimental: WallFlex Biliary RX FC Stent System - The WallFlex Biliary RX Fully Covered Stent System is being evaluated for treatment of benign biliary strictures.
Treatment: Devices: WallFlex Biliary RX Fully Covered Stent System
Temporary placement of a biliary stent as a treatment of biliary obstruction resulting from benign bile duct strictures. The stent is fully covered with a silicone polymer to reduce the potential of tissue ingrowth into the stent. The stent is removed after 5 months (±1 month) after stent placement in Post-Liver Transplant patients and after 11 months (±1 month) in Chronic Pancreatitis and Post-Abdominal Surgery patients.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Stent Removability
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Assessment method [1]
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Defined as ability to remove the stent endoscopically without serious stent removal related adverse events as assessed from the time of stent removal to 1month post-stent removal.
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Timepoint [1]
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At stent removal
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Eligibility
Key inclusion criteria
- Age 18 or older
- Willing and able to comply with the study procedures and provide written informed
consent to participate in the study
- Chronic pancreatitis or prior liver transplantation or prior other abdominal surgery
(to include cholecystectomy)
- Indicated for ERCP procedure with stent placement for: Symptomatic bile duct stricture
(i.e. obstructive jaundice, persistent cholestasis, acute cholangitis) confirmed by
cholangiogram and/or Bile duct stricture confirmed by cholangiogram and/or Exchange of
prior plastic stent(s) for management of benign stricture
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
General:
- Placement of the stent in strictures that cannot be dilated enough to pass the
delivery system
- Placement of the stent in a perforated duct
- Placement of the stent in very small intrahepatic ducts
- Patients for whom endoscopic techniques are contraindicated
- Biliary stricture of malignant etiology
- Biliary stricture of benign etiology other than chronic pancreatitis or liver
transplant anastomosis or other abdominal surgery
- Stricture within 2 cm of duct bifurcation
- Symptomatic duodenal stenosis (with gastric stasis)
- Prior biliary self-expanding metal stent
- Suspected stricture ischemia based on imaging of hepatic artery occlusion or
endoscopic evidence of biliary cast syndrome
- Known bile duct fistula
- Known sensitivity to any components of the stent or delivery system
- Participation in another investigational study within 90 days prior to consent or
during the study
Additional Specific to Chronic Pancreatitis Patients:
- Developing obstructive biliary symptoms associated with an attack of acute
pancreatitis
Additional Specific to Post-Abdominal Surgery Patients:
- History of hepatectomy
- History of liver transplant
Additional Specific to Liver Transplant Patients:
- Live donor transplantation
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/11/2017
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Sample size
Target
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Accrual to date
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Final
187
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Westmead Hospital - Westmead
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment outside Australia
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Austria
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Vienna
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Belgium
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Brussels
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Canada
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Ontario
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Canada
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Quebec
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Chile
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Santiago
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France
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Lyon
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Germany
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Dusseldorf
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India
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Hyderabad
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Italy
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Rome
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Netherlands
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Rotterdam
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Spain
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Catalunya
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Boston Scientific Corporation
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the safety and performance of the WallFlex® Biliary
RX Fully Covered Stent as a treatment of biliary obstruction resulting from benign bile duct
strictures.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01014390
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Address
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01014390
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