Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00042549
Status:
TERMINATED
Last Update Posted:
2005-06-24
First Post:
2002-07-31
Brief Title:
Lithotripsy for the Treatment of Gallstones
Sponsor:
Medstone International
Organization:
Medstone International
Study Overview
Official Title:
Biliary Lithotripsy in Combination With Actigall Versus Actigall Monotherapy for the Treatment of Symptomatic Cholesterol Gallstones
Status:
TERMINATED
Status Verified Date:
2003-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None