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Clinical Feasibility Study of Allium's Biliary Stent

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2007 by Allium, Ltd..
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00448006
First Posted: March 15, 2007
Last Update Posted: March 15, 2007
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.
Information provided by:
Allium, Ltd.
  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
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)

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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:
ClinicalTrials.gov Identifier: NCT00448006     History of Changes
Other Study ID Numbers: BIS-CL-001
First Submitted: March 14, 2007
First Posted: March 15, 2007
Last Update Posted: March 15, 2007
Last Verified: March 2007

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