Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction

This study has been completed.
Sponsor:
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00713427
First received: July 9, 2008
Last updated: August 31, 2009
Last verified: August 2009

July 9, 2008
August 31, 2009
July 2007
May 2008   (final data collection date for primary outcome measure)
The primary outcome measured will be the adequate clinical palliation of the biliary obstruction defined as absence of recurrent biliary obstruction. Recurrent biliary obstruction will be determined by treating physicians. [ Time Frame: 6 months or death, whichever comes first ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00713427 on ClinicalTrials.gov Archive Site
Secondary outcome measures include the occurrence, severity, device- and procedure-relatedness of adverse events, device deployability and removability, re-interventions, biliary obstruction symptoms, liver function, and recurrent biliary obstruction. [ Time Frame: 6 months or death, whichever comes first ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction
A Multi-Center, Single Arm, Prospective Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction

This is a a prospective study of the WallFlex™ Biliary Partially-covered Stent designed to collect data to support regulatory clearance by the FDA in the United States and to determine the functionality of the WallFlex™ Biliary Partially Covered Stent as a Palliative treatment for malignant bile duct obstruction.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Biliary Strictures Caused by Malignant Neoplasms
Device: WallFlex™ Biliary Partially-Covered Stent
Implantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is partially covered with a polymer to reduce the potential for tumor ingrowth through the stent.
WallFlex Stent
All patients meeting eligibility criteria recieve the WallFlex™ Biliary Partially-Covered Stent, which has regulatory clearance in the areas in which the study is being conducted.
Intervention: Device: WallFlex™ Biliary Partially-Covered Stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
May 2008
May 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18 years or older
  • Inoperable extrahepatic biliary obstruction by any malignant process
  • Indicated for metal stent placement for palliative treatment of biliary stricture(s) produced by malignant neoplasms
  • Willing and able to comply with the study procedures and provide written informed consent to participate in the study

Exclusion Criteria:

  • Participation in another invesitgational study within 90 days prior to date of patient consent.
  • Strictures that cannot be dialated enough to pass the delivery system
  • Perforation of any duct within the biliary tree
  • Presence of any esophageal or duodenal stent
  • Patients for whom endoscopic procedures are contraindicated
  • Patients with known senesitivity to any components of the stent or delivery system
  • Patients with active hepatitis
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France,   Germany,   India,   Italy,   Netherlands
 
NCT00713427
ENDO-WALLFLEX-BIL-PALL-002, E7020
Yes
Jeremy Bolt, Boston Scientific
Boston Scientific Corporation
Not Provided
Study Director: Robert Walsh, M.D. Boston Scientific Corporation
Principal Investigator: Guido Costamagna, M.D. Università Cattolica del Sacro Cuore, Policlinico A. Gemelli
Boston Scientific Corporation
August 2009

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