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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: October 7, 2014
Last verified: October 2014

November 13, 2009
October 7, 2014
December 2009
November 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01014390 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
WallFlex Biliary Fully Covered (FC) Benign Stricture Study
A Multi-Center, Prospective Study of the WallFlex Biliary RX Fully Covered Stent for the Treatment of Benign Biliary Strictures

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Biliary Stricture
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.
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
Devière J, Nageshwar Reddy D, Püspök A, Ponchon T, Bruno MJ, Bourke MJ, Neuhaus H, Roy A, González-Huix Lladó F, Barkun AN, Kortan PP, Navarrete C, Peetermans J, Blero D, Lakhtakia S, Dolak W, Lepilliez V, Poley JW, Tringali A, Costamagna G; Benign Biliary Stenoses Working Group. Successful management of benign biliary strictures with fully covered self-expanding metal stents. Gastroenterology. 2014 Aug;147(2):385-95; quiz e15. doi: 10.1053/j.gastro.2014.04.043. Epub 2014 May 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
187
November 2017
November 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Belgium,   Canada,   Chile,   France,   Germany,   India,   Italy,   Netherlands,   Spain
 
NCT01014390
CDM 00027550
No
Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Not Provided
Boston Scientific Corporation
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP