Lithotripsy for the Treatment of Gallstones

Medstone International

Status and phase

Terminated

Phase 4

Conditions

Cholelithiasis

Treatments

Drug: ursodiol

Device: Extracorporeal Shock Wave Lithotripsy

Study type

Interventional

Funder types

Industry

Identifiers

NCT00042549

GS-PA-001

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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