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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
WallFlex Biliary Fully Covered (FC) Benign Stricture Study
Scientific title
A Multi-Center, Prospective Study of the WallFlex Biliary RX Fully Covered Stent for the Treatment of Benign Biliary Strictures
Secondary ID [1] 0 0
CDM 00027550
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Biliary Stricture 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Study type
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.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Stent Removability, defined as ability to remove the stent endoscopically without serious stent-removal related adverse events as assessed from the time of stent removal to 1 month post-stent removal.
Timepoint [1] 0 0
Time from stent removal to 1 month post-stent removal
Secondary outcome [1] 0 0
Stricture resolution during stent indwell, defined by lack of stent-related re-interventions
Timepoint [1] 0 0
Up to 12 months
Secondary outcome [2] 0 0
Stricture resolution after stent removal, defined by lack of stricture-related re-intervention
Timepoint [2] 0 0
Up to 60 months after stent removal
Secondary outcome [3] 0 0
Occurrence and severity of adverse events related to the stent and/or the procedure
Timepoint [3] 0 0
Entire study
Secondary outcome [4] 0 0
Ability to deploy the stent in satisfactory position across the stricture (technical success at placement)
Timepoint [4] 0 0
Stent placement procedure
Secondary outcome [5] 0 0
Length of stent placement procedure, length of stent removal procedure and methods of removal (to include video recording if available)
Timepoint [5] 0 0
Stent placement through removal
Secondary outcome [6] 0 0
Biliary obstructive symptom assessment at all visits: Right Upper Quadrant Pain, Fever/Chills, Jaundice, Itching, Dark urine, Pale stools, Nausea/Vomiting
Timepoint [6] 0 0
Entire Study
Secondary outcome [7] 0 0
Liver Function Tests (LFT's) at baseline, at month 1 post-stent placement, at stent removal and at months 6, 12 and 24 post-stent removal
Timepoint [7] 0 0
Up to 24 months post-stent removal

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
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria

- 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

Additional Specific to Post-Abdominal Surgery Patients:

- History of hepatectomy

- History of liver transplant

Additional Specific to Liver Transplant Patients:

- Live donor transplantation

Study design
Purpose of the study
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Single group
Other design features
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
State/province [1] 0 0
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State/province [2] 0 0
Country [3] 0 0
State/province [3] 0 0
Country [4] 0 0
State/province [4] 0 0
Country [5] 0 0
State/province [5] 0 0
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State/province [6] 0 0
Country [7] 0 0
State/province [7] 0 0
Country [8] 0 0
State/province [8] 0 0
Country [9] 0 0
State/province [9] 0 0
Country [10] 0 0
State/province [10] 0 0
Country [11] 0 0
State/province [11] 0 0

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Boston Scientific Corporation

Ethics approval
Ethics application status

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
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
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Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see