Extracorporeal Shock Wave Lithotriptor Indicated for Fragmenting Urinary Stones in the Kidney

Status unconfirmed · Phase 3

Conditions studied: Kidney Stones

In brief

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 for 14 days. If at the 14 day follow-up visit the subject continues to present with a stone size 4 mm or greater will have an option of retreatment or other intervention. If the subject consents to be retreated at this time, this subject will be followed up for another 14 days.

Key facts

Study ID

NCT00959153

Run by

Advance Shockwave Technology GmbH

People needed

20

Starts

2010-06-01

Expected to finish

2011-08-01

Last updated by the study team

2011-06-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Metropolitan Lithotriptor Associates — Garden City, New York, United States
• Allied Urological Services, LLC — New York, New York, United States

Full record on ClinicalTrials.gov

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