Lithotripsy for the Treatment of Gallstones
Biliary Lithotripsy in Combination With Actigall Versus Actigall Monotherapy for the Treatment of Symptomatic Cholesterol Gallstones
  • Phase

    Phase 4
  • Study Type

  • Status

  • Study Participants

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.
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 Started
May 31
Last Update
Jun 24

Device Extracorporeal Shock Wave Lithotripsy

Drug ursodiol


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
No Results Posted