Lithotripsy for the Treatment of Gallstones

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: NCT00042549
Recruitment Status : Terminated
First Posted : August 5, 2002
Last Update Posted : June 24, 2005
Information provided by:
Medstone International

Brief Summary:
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 or disease Intervention/treatment Phase
Cholelithiasis Device: Extracorporeal Shock Wave Lithotripsy Drug: ursodiol Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Biliary Lithotripsy in Combination With Actigall Versus Actigall Monotherapy for the Treatment of Symptomatic Cholesterol Gallstones
Study Start Date : May 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gallstones
Drug Information available for: Ursodiol
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
  • 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

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): NCT00042549

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

Additional Information:
Publications: Identifier: NCT00042549     History of Changes
Other Study ID Numbers: GS-PA-001
First Posted: August 5, 2002    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: June 2003

Keywords provided by Medstone International:
Biliary stones
Gallbladder stones
Shock wave
Shock waves

Additional relevant MeSH terms:
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Pathological Conditions, Anatomical