Status:
UNKNOWN
Extracorporeal Shock Wave Lithotriptor Indicated for Fragmenting Urinary Stones in the Kidney
Lead Sponsor:
Advance Shockwave Technology GmbH
Conditions:
Kidney Stones
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A total of 20 subjects presenting with urinary stone(s) in the kidney or ureter will be treated with an extracorporeal shockwave lithotripsy device to fragment the stones. Subjects will be followed fo...
Eligibility Criteria
Inclusion
- Diagnosis of a solitary Urinary stones in the renal pelvis or renal calyces or ureter
- Presence of one stone greater than 4 mm and less than 12 mm
Exclusion
- Urinary tract obstruction, acute or unresolved cholecystitis, cholangitis, pancreatitis or obstruction of the biliary duct system
- Impaction of stone to be treated
- Staghorn stones
- Failed or inadequate lithotripsy procedure within 3 months prior to study
- Coagulation abnormalities or anticoagulation therapy
- Pregnant or females of child-bearing potential General, spinal or epidural anesthesia is contraindicated
- Can not be positioned correctly for fluoroscopic imaging
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00959153
Start Date
June 1 2010
End Date
August 1 2011
Last Update
June 1 2011
Active Locations (2)
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1
Metropolitan Lithotriptor Associates
Garden City, New York, United States, 11530
2
Allied Urological Services, LLC
New York, New York, United States, 10016