WithdrawnNot Applicable

Clinical Feasibility Study of Allium's Biliary Stent

Israel0Started 2008-04

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Timeframe: up to 12 months follow up

Trial details

NCT IDNCT00448006

SponsorAllium, Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-08

View on ClinicalTrials.gov More Malignant Obstruction of the Common Bile Duct trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.