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NCT00433771 · ClinicalTrials.gov registry record · Phase 3
A Study of the WallFlex™ Biliary Fully-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction
A Phase 3 study of Cholestasis, Extrahepatic, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 74
- Enrollment target
- 10
- Study locations
NCT00433771: Completed Phase 3 study of Cholestasis, Extrahepatic, sponsored by Boston Scientific Corporation.
NCT00433771 is a Phase 3 study of Cholestasis, Extrahepatic that has completed, run by Boston Scientific Corporation. The registered enrollment target is 74 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). The trial reports 10 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00433771, a Phase 3 study of Cholestasis, Extrahepatic, has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 74 participants
- Enrollment target
- 10
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE WallFlex™ Biliary Fully Covered Metal Stent placement
Study Locations (10)
Minnesota
- Hennepin County Medical Center - Minneapolis
- Mayo Clinic - Rochester
California
- California Pacific Medical Center - San Francisco
Colorado
- Univ. of Colorado Health Sciences - Aurora
Missouri
- Washington University School of Medicine - St Louis
North Carolina
- Duke University Med Center - Durham
Pennsylvania
- Thomas Jefferson University - Philadelphia
Texas
- MD Anderson Cancer Center - Houston
Virginia
- Univ. of VA Medical Center - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2007-03 |
| Est. Completion | 2008-05 |
| Phase | Phase 3 |
What the finished NCT00433771 record still lists
NCT00433771 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Cholestasis, Extrahepatic appearing as the primary indexed condition, and to 1 intervention - of which WallFlex™ Biliary Fully Covered Metal Stent placement is the first listed.
NCT00433771 lists 10 locations in 9 states (Minnesota, California, Colorado).
Frequently Asked Questions
What is clinical trial NCT00433771 about?
NCT00433771 is a clinical study titled "A Study of the WallFlex™ Biliary Fully-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction". 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.
What is the current status of trial NCT00433771?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 74 participants. The study started on 2007-03. Estimated completion is 2008-05.
What conditions does trial NCT00433771 study?
This clinical trial studies the following conditions: Cholestasis, Extrahepatic.
What interventions are being tested in trial NCT00433771?
The interventions under investigation include: WallFlex™ Biliary Fully Covered Metal Stent placement (DEVICE).
Who is sponsoring clinical trial NCT00433771?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00433771 being conducted?
This trial has 10 study locations across California, Colorado, Minnesota, Missouri, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00433771's enrollment target sits among peer trials
74 1780th of 2000 higher than 221 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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