Clinical Feasibility Study of Allium's Biliary Stent

Allium, Ltd.

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Malignant Obstruction of the Common Bile Duct

Interventions

Allium Biliary StentDEVICE

device

allium biliary stentDEVICE

allium biliary stent

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * 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)

Locations (1)

Sheba Medical Center

Ramat Gan, Israel

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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