Status:
WITHDRAWN
Clinical Feasibility Study of Allium's Biliary Stent
Lead Sponsor:
Allium, Ltd.
Conditions:
Malignant Obstruction of the Common Bile Duct
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of the Allium Biliary Stent in malignant obstructions of the common bile duct.
Detailed Description
Biliary duct stenoses are caused by intrinsic malignant disease of the common bile duct or by compression or infiltration of malignancies of the abdominal organs, i.e. pancreas, liver, stomach, duoden...
Eligibility Criteria
Inclusion
- Patient is 18 years or older
- Patient has malignant obstructive jaundice
- Patient is unfit for surgery
- Patient is capable of giving informed consent
- Patient is willing to comply with study requirements
Exclusion
- Patient has a benign biliary duct obstruction
- Patient cannot tolerate any form of antibiotic treatment
- Patient is currently receiving anticoagulation therapy
- Patient has history of illness, medication, or surgery that may affect the efficacy of the stent (e.g.: a previous surgical change in the anatomy of the common bile duct)
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00448006
Start Date
April 1 2008
Last Update
July 10 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sheba Medical Center
Ramat Gan, Israel