Clinical Feasibility Study of Allium's Biliary Stent
Recruitment status was Not yet recruiting
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Clinical Feasibility Study to Evaluate the New Allium Biliary Stent, in Patients Suffering From “Malignant Biliary Duct Obstruction” (Endoscopic Insertion)|
- 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.
|Study Start Date:||April 2007|
|Estimated Study Completion Date:||December 2008|
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.
|Contact: Simon Bar-Meir, M.D.||+email@example.com|
|Sheba Medical Center||Not yet recruiting|
|Ramat Gan, Israel|
|Sub-Investigator: Simon Bar-Meir, M.D.|
|Principal Investigator: Carlos Simon, M.D.|
|Sub-Investigator: Alon Lang, M.D.|
|Sub-Investigator: Maor Lahav, M.D.|
|Principal Investigator:||Simon Bar-Meir, M.D.||Sheba Medical Center|