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Sponsored by: |
Medstone International |
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Information provided by: | Medstone International |
ClinicalTrials.gov Identifier: | NCT00042549 |
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.
Condition | Intervention | Phase |
---|---|---|
Cholelithiasis |
Device: Extracorporeal Shock Wave Lithotripsy Drug: ursodiol |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Biliary Lithotripsy in Combination With Actigall Versus Actigall Monotherapy for the Treatment of Symptomatic Cholesterol Gallstones |
Estimated Enrollment: | 184 |
Study Start Date: | May 2002 |
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.
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
United States, Texas | |
The Methodist Hospital | |
Houston, Texas, United States, 77030 | |
United States, Virginia | |
Virgina Commonwealth University | |
Richmond, Virginia, United States, 23298 |
Study Director: | Atilla Ertan, M.D. | The Methodist Hospital System |
Study ID Numbers: | GS-PA-001 |
Study First Received: | July 31, 2002 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00042549 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Gallstones Gallstone Biliary stones Gallbladder stones Gallbladder Lithotripsy |
Cholelithiasis ESWL Shock wave Shock waves shockwaves shockwave |
Pathological Conditions, Anatomical Gallbladder Diseases Cholecystolithiasis Digestive System Diseases Cholelithiasis |
Shock Gallstones Biliary Tract Diseases Calculi Ursodeoxycholic Acid |
Pathological Conditions, Anatomical Gallbladder Diseases Cholecystolithiasis Digestive System Diseases |
Cholelithiasis Gallstones Biliary Tract Diseases Calculi |