Clinical Trial: Lithotripsy for the Treatment of Gallstones

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: Medstone International

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Medstone International

Dates:
Date Received: July 31, 2002
Date Started: May 2002
Date Completion:
Last Updated: June 23, 2005
Last Verified: June 2003