Clinical Feasibility Study of Allium's Biliary Stent

Malignant Obstruction of the Common Bile Duct Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00448006
• Other study ID #: BIS-CL-001
• Status: Withdrawn
• Phase: N/A
• Start date: April 2008

Study information

• Verified date: April 2008
• Source: Allium, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Malignant Obstruction of the Common Bile Duct

Intervention

Device:
• Allium Biliary Stent
device
• allium biliary stent
allium biliary stent

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Allium, Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   The Chaim Sheba Medical Center at Tel Hashomer