Clinical Feasibility Study of Allium's Biliary Stent

Allium

Status

Withdrawn

Conditions

Malignant Obstruction of the Common Bile Duct

Treatments

Device: allium biliary stent

Device: Allium Biliary Stent

Study type

Interventional

Funder types

Industry

Identifiers

NCT00448006

BIS-CL-001

Details and patient eligibility

About

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.

Full 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, 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)