An interventional study of Allium Biliary Stent and allium biliary stent in Malignant Obstruction of the Common Bile Duct, sponsored by Allium, Ltd.. Withdrawn at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-10.
Sponsored by Allium, Ltd. · Not applicable, Interventional, and Treatment
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.
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, duodenum, etc, or by iatrogenic reasons such as endoscopic biliary stone manipulations, biliary anastomoses or biliary duct reimplantation. In these diseases, a stent can be placed in the biliary duct canal to "open it" and relieve the obstruction. The Allium Biliary Stent is to be inserted into the biliary duct to allow free flow of biliary fluid from the liver to the duodenum by supporting the obstructed area of the biliary duct lumen, keep it open, and prevent its re-obstruction.
Allium, Ltd. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
device
allium biliary stent
Also known as: self expandable stent
Body temperature measurement, patient comfort analysis, sonographic measurements of the duct channels, abdominal X-ray imaging of the stent, and blood tests will be performed at 24 hours, 30 days, 3, 6, and 12 months following stent insertion.
Time frame: up to 12 months follow up
This study is withdrawn, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.
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Allium, Ltd.