Lithotripsy for the Treatment of Gallstones

This study has been terminated.
Sponsor:
Information provided by:
Medstone International
ClinicalTrials.gov Identifier:
NCT00042549
First received: July 31, 2002
Last updated: June 23, 2005
Last verified: June 2003
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Biliary Lithotripsy in Combination With Actigall Versus Actigall Monotherapy for the Treatment of Symptomatic Cholesterol Gallstones

Resource links provided by NLM:


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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00042549     History of Changes
Other Study ID Numbers: GS-PA-001
Study First Received: July 31, 2002
Last Updated: June 23, 2005
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

Additional relevant MeSH terms:
Cholelithiasis
Cholecystolithiasis
Gallstones
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical
Ursodeoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014