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Lithotripsy for the Treatment of Gallstones

This study has been terminated.

Sponsored by: Medstone International
Information provided by: Medstone International
ClinicalTrials.gov Identifier: NCT00042549
  Purpose

The purpose of this study is to determine the effectiveness and safety of using the Medstone lithotripter to treat single non-calcified gallstones from 4 to 20 mm in diameter.


Condition Intervention Phase
Cholelithiasis
Device: Extracorporeal Shock Wave Lithotripsy
Drug: ursodiol
Phase IV

MedlinePlus related topics:   Gallstones   

ChemIDplus related topics:   Cholest-5-en-3-ol (3beta)-    Ursodeoxycholic acid   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Biliary Lithotripsy in Combination With Actigall Versus Actigall Monotherapy for the Treatment of Symptomatic Cholesterol Gallstones

Further study details as provided by Medstone International:

Estimated Enrollment:   184
Study Start Date:   May 2002

Detailed Description:

This study is a randomized, single-masked controlled trial in which the combination therapy of lithotripsy and the bile acid drug Actigall is compared to monotherapy with only Actigall. The primary objectives are, 1) To determine whether the use of the Medstone STS Lithotripter system in combination with the orally administered drug Actigall is more effective (as measured by percentages of stone free patients 6 months after randomization) in reducing single non-calcified radiolucent gallstones (from 4 to 20mm in diameter) than use of Actigall alone, and 2) To demonstrate that use of the Medstone lithotripsy system is safe (as measured by incidence of adverse events) for the intended purpose, when operated according to its labeling.

  Eligibility
Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria
  • History of biliary pain
  • Evidence of a single noncalcified, radiolucent gallstone between 4 and 20 mm (inclusive) diameter
  • HIDA scan demonstrating patency of cystic bile duct
  • No cardiac pacemaker
  • No allergy to radioopaque dye, iodine, bile acids
  • No spontaneous or iatrogenic bleeding disorder
  • No current or prior bile duct obstruction, cholangitis, pancreatitis, or cholecystitis
  • Not pregnant
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00042549

Locations
United States, Texas
The Methodist Hospital    
      Houston, Texas, United States, 77030
United States, Virginia
Virgina Commonwealth University    
      Richmond, Virginia, United States, 23298

Sponsors and Collaborators
Medstone International

Investigators
Study Director:     Atilla Ertan, M.D.     The Methodist Hospital System    
  More Information

UpToDate is a practical clinical information service (always current). It is written by a recognized faculty of experts who each address a specific clinical issue. They synthesize the latest evidence and best practices.  This link exits the ClinicalTrials.gov site
 

Publications:

Study ID Numbers:   GS-PA-001
First Received:   July 31, 2002
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00042549
Health Authority:   United States: Food and Drug Administration

Keywords provided by Medstone International:
Gallstones  
Gallstone  
Biliary stones  
Gallbladder stones  
Gallbladder  
Lithotripsy  
Cholelithiasis
ESWL
Shock wave
Shock waves
shockwaves
shockwave

Study placed in the following topic categories:
Pathological Conditions, Anatomical
Gallbladder Diseases
Cholecystolithiasis
Digestive System Diseases
Cholelithiasis
Shock
Gallstones
Biliary Tract Diseases
Calculi
Ursodeoxycholic Acid

ClinicalTrials.gov processed this record on September 05, 2008




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