Clinical Feasibility Study of Allium's Biliary Stent

A Clinical Feasibility Study to Evaluate the New Allium Biliary Stent, in Patients Suffering From Malignant Biliary Duct Obstruction (Endoscopic Insertion)

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00448006

Enrollment

Registered

2007-03-15

Start date

2008-04-30

Completion date

Unknown

Last updated

2018-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Obstruction of the Common Bile Duct

Keywords

common, bile, duct, biliary, malignant, obstruction, stent

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, 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.

Interventions

DEVICEAllium Biliary Stent

device

DEVICEallium biliary stent

allium biliary stent

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame
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.	up to 12 months follow up

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026