Lithotripsy for the Treatment of Gallstones - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

July 31, 2002

Last Updated Date

June 23, 2005

Start Date ^†

May 2002

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00042549 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Lithotripsy for the Treatment of Gallstones

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 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.

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Cholelithiasis

Intervention ^†

Device: Extracorporeal Shock Wave Lithotripsy
Drug: ursodiol

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Terminated

Enrollment ^†

184

Completion Date

Primary Completion Date

Eligibility 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

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00042549

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Medstone International

Collaborators ^††

Investigators ^†

Study Director:

Atilla Ertan, M.D.

The Methodist Hospital System

Information Provided By

Medstone International

Verification Date

June 2003

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.