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Clinical Feasibility Study of Allium's Biliary Stent

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by Allium, Ltd..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Allium, Ltd.
ClinicalTrials.gov Identifier:
NCT00448006
First received: March 14, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
  Purpose

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 Intervention
Malignant Obstruction of the Common Bile Duct
 Device: Allium Biliary Stent

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Further study details as provided by Allium, Ltd.:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 30
Study Start Date: April 2007
Estimated Study Completion Date: December 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00448006

Contacts
Contact: Simon Bar-Meir, M.D. +972-3-530-2909 barmeirs@yahoo.com

Locations
Israel
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.
Investigators
Principal Investigator: Simon Bar-Meir, M.D. Sheba Medical Center
  More Information

Additional Information:
The Chaim Sheba Medical Center at Tel Hashomer  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00448006     History of Changes
Other Study ID Numbers: BIS-CL-001
Study First Received: March 14, 2007
Last Updated: March 14, 2007
Health Authority: Israel: Ministry of Health

Keywords provided by Allium, Ltd.:
common
bile
duct
biliary
 malignant
obstruction
stent

ClinicalTrials.gov processed this record on May 23, 2013