WallFlex Biliary Fully Covered (FC) Benign Stricture Study

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Boston Scientific Corporation

ClinicalTrials.gov Identifier:

NCT01014390

First received: November 13, 2009

Last updated: April 26, 2013

Last verified: April 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	November 13, 2009
Last Updated Date	April 26, 2013
Start Date ^ICMJE	December 2009
Primary Completion Date	November 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 16, 2009)	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. [ Time Frame: Time from stent removal to 1 month post-stent removal ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01014390 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 16, 2009)	Stricture resolution during stent indwell, defined by lack of stent-related re-interventions [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ] Stricture resolution after stent removal, defined by lack of stricture-related re-intervention [ Time Frame: Up to 60 months after stent removal ] [ Designated as safety issue: No ] Occurrence and severity of adverse events related to the stent and/or the procedure [ Time Frame: Entire study ] [ Designated as safety issue: Yes ] Ability to deploy the stent in satisfactory position across the stricture (technical success at placement) [ Time Frame: Stent placement procedure ] [ Designated as safety issue: No ] Length of stent placement procedure, length of stent removal procedure and methods of removal (to include video recording if available) [ Time Frame: Stent placement through removal ] [ Designated as safety issue: No ] Biliary obstructive symptom assessment at all visits: Right Upper Quadrant Pain, Fever/Chills, Jaundice, Itching, Dark urine, Pale stools, Nausea/Vomiting [ Time Frame: Entire Study ] [ Designated as safety issue: No ] 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 [ Time Frame: Up to 24 months post-stent removal ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	WallFlex Biliary Fully Covered (FC) Benign Stricture Study
Official Title ^ICMJE	A Multi-Center, Prospective Study of the WallFlex Biliary RX Fully Covered Stent for the Treatment of Benign Biliary Strictures
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Biliary Stricture
Intervention ^ICMJE	Device: 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.
Study Arm (s)	Experimental: WallFlex Biliary RX FC Stent System The WallFlex Biliary RX Fully Covered Stent System is being evaluated for treatment of benign biliary strictures. Intervention: Device: WallFlex Biliary RX Fully Covered Stent System
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	187
Estimated Completion Date	November 2017
Primary Completion Date	November 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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 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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Australia, Austria, Belgium, Canada, Chile, France, Germany, India, Italy, Netherlands, Spain

Administrative Information
NCT Number ^ICMJE	NCT01014390
Other Study ID Numbers ^ICMJE	CDM 00027550
Has Data Monitoring Committee	No
Responsible Party	Boston Scientific Corporation
Study Sponsor ^ICMJE	Boston Scientific Corporation
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Boston Scientific Corporation
Verification Date	April 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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