Clinical Feasibility Study of Allium's Biliary Stent

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00448006
Recruitment Status : Unknown
Verified March 2007 by Allium, Ltd..
Recruitment status was:  Not yet recruiting
First Posted : March 15, 2007
Last Update Posted : March 15, 2007
Information provided by:
Allium, Ltd.

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.

Condition or disease Intervention/treatment Phase
Malignant Obstruction of the Common Bile Duct Device: Allium Biliary Stent Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Feasibility Study to Evaluate the New Allium Biliary Stent, in Patients Suffering From “Malignant Biliary Duct Obstruction” (Endoscopic Insertion)
Study Start Date : April 2007
Study Completion Date : December 2008

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00448006

Contact: Simon Bar-Meir, M.D. +972-3-530-2909

Sheba Medical Center Not yet recruiting
Ramat Gan, Israel
Sub-Investigator: Simon Bar-Meir, M.D.         
Principal Investigator: Carlos Simon, M.D.         
Sub-Investigator: Alon Lang, M.D.         
Sub-Investigator: Maor Lahav, M.D.         
Sponsors and Collaborators
Allium, Ltd.
Principal Investigator: Simon Bar-Meir, M.D. Sheba Medical Center

Additional Information: Identifier: NCT00448006     History of Changes
Other Study ID Numbers: BIS-CL-001
First Posted: March 15, 2007    Key Record Dates
Last Update Posted: March 15, 2007
Last Verified: March 2007

Keywords provided by Allium, Ltd.: