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A Multi-Center, Single Arm, Prospective Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction


N/A
18 Years
N/A
Not Enrolling
Both
Biliary Strictures Caused by Malignant Neoplasms

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Trial Information

A Multi-Center, Single Arm, Prospective Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Time Frame:

6 months or death, whichever comes first

Safety Issue:

Yes

Principal Investigator

Robert Walsh, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Boston Scientific Corporation

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

ENDO-WALLFLEX-BIL-PALL-002

NCT ID:

NCT00713427

Start Date:

July 2007

Completion Date:

May 2008

Related Keywords:

  • Biliary Strictures Caused by Malignant Neoplasms
  • Biliary
  • Strictures
  • Malignant
  • Neoplasm
  • Palliation
  • Neoplasms
  • Cholestasis
  • Constriction, Pathologic

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