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Home > "L" Clinical Trials Conditions > Lithotripsy for the Treatment of Gallstones  Lithotripsy for the Treatment of Gallstones
Lithotripsy for the Treatment of Gallstones
For Condition: Cholelithiasis
Status: Terminated
Sponsor(s): Medstone International ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/90 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 184
Location and Contact Information:
Overall Study Official:
AtillaErtan, Study Director, The Methodist Hospital
The Methodist Hospital
Houston, Texas, 77030
United States
Virgina Commonwealth University
Richmond, Virginia, 23298
United States
Additional Information:
Study ID Numbers: GS-PA-001;
Study Start Date: May 2002
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00042549
Other Cholelithiasis Studies:
1. Lithotripsy for the Treatment of Gallstones
Related Studies:
Other Cholelithiasis Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Lithotripsy for the Treatment of Gallstones
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