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Stent
WallFlex Biliary Post Liver Transplant IDE Pilot
N/A
Waitlist Available
Led By Divyesh Sejpal, M.D.
Research Sponsored by Boston Scientific Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post stent removal
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Anastomotic Biliary Stricture
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months post stent removal
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post stent removal
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Stricture Resolution at the Time of Stent Removal.
Secondary study objectives
Effectiveness of Stent at 6 Months
Re-intervention Occurrence
Safety
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: WallFlex Biliary Fully Covered StentExperimental Treatment1 Intervention
All eligible patients entered into the study will be treated with a WallFlex Biliary Fully Covered Stent
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
WallFlex Biliary Fully Covered Stent
2009
N/A
~10
Find a Location
Who is running the clinical trial?
Boston Scientific CorporationLead Sponsor
746 Previous Clinical Trials
857,979 Total Patients Enrolled
Divyesh Sejpal, M.D.Principal InvestigatorIcahn School of Medicine at Mount Sinai