NCT00433771

Brief Summary

The overall objective of this study is to assess the functionality of the WallFlex™ Biliary Fully-covered stent as a palliative treatment for malignant bile duct obstruction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 12, 2007

Completed
17 days until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

February 9, 2010

Completed
Last Updated

June 29, 2010

Status Verified

June 1, 2010

Enrollment Period

1.2 years

First QC Date

February 8, 2007

Results QC Date

September 25, 2009

Last Update Submit

June 21, 2010

Conditions

Cholestasis, Extrahepatic

Keywords

MalignantCholestasis, ExtrahepaticBiliary obstruction

Outcome Measures

Primary Outcomes (1)

  • Adequate Clinical Palliation of the Biliary Obstruction

    Adequate clinical palliation of the biliary obstruction as demonstrated by the absence of stent occlusion within 6 month follow up or prior to death, whichever comes first in the evaluable subject cohort of 55 patients.

    6 months

Secondary Outcomes (12)

  • Technical Success

    At treatment

  • Ability to Successfully Remove a Stent Upon Removal Attempt

    6 months

  • Re-interventions

    Until 6 months or death

  • Clinical Success at 1 Month After Stent Procedure as Defined by Reduction of Biliary Obstruction Symptoms

    1 Month

  • Clinical Success at 3 Months After Stent Procedure as Defined by the Reduction of Biliary Obstruction Symptoms

    3 months

  • +7 more secondary outcomes

Study Arms (1)

WallFlex Biliary Fully Covered stent

EXPERIMENTAL

Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent

Device: WallFlex™ Biliary Fully Covered Metal Stent placement

Interventions

WallFlex™ Biliary Fully Covered Metal Stent placementDEVICE

Implantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is fully covered with a polymer to reduce the potential for tumor ingrowth into the stent.

WallFlex Biliary Fully Covered stent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or older
  • Clinical symptoms of biliary obstruction
  • Inoperable extrahepatic biliary obstruction by any malignant process
  • Willing and able to comply with the study procedures and provide written informed consent to participate in the study.

You may not qualify if:

  • Participation in an Investigational Study within 90 days prior to date of patient consent
  • Strictures that cannot be dilated enough to pass the delivery system
  • Perforation of any duct within the biliary tree
  • Presence of a metal biliary stent
  • Presence of any esophageal or duodenal stent
  • Patients for whom endoscopic procedures are contraindicated
  • Patients with known sensitivity to any components of the stent or delivery system
  • Patients with active hepatitis or intrahepatic metastases that extensively involves both lobes of the liver
  • Patients with an anticipated life expectancy of \< 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

California Pacific Medical Center

San Francisco, California, 94115, United States

Location

Univ. of Colorado Health Sciences

Aurora, Colorado, 80010, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Duke University Med Center

Durham, North Carolina, 27710, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Univ. of VA Medical Center

Charlottesville, Virginia, 800708, United States

Location

Virginia Mason Seattle Main Clinic

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Cholestasis, Extrahepatic

Condition Hierarchy (Ancestors)

CholestasisBile Duct DiseasesBiliary Tract DiseasesDigestive System Diseases

Results Point of Contact

Title
Jeremy Bolt
Organization
Boston Scientific Corporation
boltj@bsci.com
508-683-4006

Study Officials

  • Bret Petersen, MD

    Mayo Clinic, Rochester, MN

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 8, 2007

First Posted

February 12, 2007

Study Start

March 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

June 29, 2010

Results First Posted

February 9, 2010

Record last verified: 2010-06

Locations

US(10)