NCT00042549

Lithotripsy for the Treatment of Gallstones

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 184 (planned)
• Sponsor: Medstone International · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Cholelithiasis

Interventions

Type	Name	Description
DEVICE	Extracorporeal Shock Wave Lithotripsy
DRUG	ursodiol

Timeline

• Start date: 2002-05-01
• First posted: 2002-08-05
• Last updated: 2005-06-24

Locations

2 sites across 1 country: United States