Lithotripsy for the Treatment of Gallstones

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

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.

• 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