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NCT01151280 · ClinicalTrials.gov registry record · NA
WallFlex Biliary Post Liver Transplant IDE Pilot
A NA study of Anastomotic Biliary Stricture Post Orthotopic Liver Transplant, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
- 2
- Study locations
NCT01151280: Completed NA study of Anastomotic Biliary Stricture Post Orthotopic Liver Transplant, sponsored by Boston Scientific Corporation.
NCT01151280 is a NA study of Anastomotic Biliary Stricture Post Orthotopic Liver Transplant that has completed, run by Boston Scientific Corporation. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01151280, a NA study of Anastomotic Biliary Stricture Post Orthotopic Liver Transplant, has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
- 2
- Study locations
Study Summary
The primary objective of this study is to demonstrate effectiveness of the WallFlex Biliary RX Fully Covered Stent for anastomotic biliary strictures in post-orthotopic liver transplant (OLT) patients.
Primary Outcome
Stricture resolution is assessed at the time of stent removal. Stricture resolution is confirmed by cholangiogram and/or balloon sweep of the biliary duct. Stent removal can be per-protocol (3 months indwell) or early.
Conditions Studied
Interventions
- DEVICE WallFlex Biliary Fully Covered Stent
Study Locations (2)
New York
- Mount Sinai Medical Center - New York
Ohio
- Mansour Parsi, MD - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2009-10 |
| Est. Completion | 2012-12 |
| Phase | NA |
What the finished NCT01151280 record still lists
NCT01151280 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Anastomotic Biliary Stricture Post Orthotopic Liver Transplant appearing as the primary indexed condition, and to 1 intervention - of which WallFlex Biliary Fully Covered Stent is the first listed.
NCT01151280 reports a single indexed study location in New York, Ohio.
Frequently Asked Questions
What is clinical trial NCT01151280 about?
NCT01151280 is a clinical study titled "WallFlex Biliary Post Liver Transplant IDE Pilot". The primary objective of this study is to demonstrate effectiveness of the WallFlex Biliary RX Fully Covered Stent for anastomotic biliary strictures in post-orthotopic liver transplant (OLT) patients.
What is the current status of trial NCT01151280?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2009-10. Estimated completion is 2012-12.
What conditions does trial NCT01151280 study?
This clinical trial studies the following conditions: Anastomotic Biliary Stricture Post Orthotopic Liver Transplant.
What interventions are being tested in trial NCT01151280?
The interventions under investigation include: WallFlex Biliary Fully Covered Stent (DEVICE).
Who is sponsoring clinical trial NCT01151280?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01151280 being conducted?
This trial has 2 study locations across New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01151280's enrollment target sits among peer trials
10 1927th of 2000 higher than 26 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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