Lithotripsy for the Treatment of Gallstones

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medstone International
• Treatments: Ursodeoxycholic Acid

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