Extracorporeal Shock Wave Lithotriptor Indicated for Fragmenting Urinary Stones in the Kidney
This trial is active, not recruiting.
|Treatment||lithospace extracorporeal shockwave lithotripter|
|Sponsor||Advance Shockwave Technology GmbH|
|Start date||June 2010|
|End date||August 2011|
|Trial size||20 participants|
|Trial identifier||NCT00959153, G080108|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
time frame: 14 days
Male or female participants at least 18 years old.
Inclusion Criteria: - 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 Criteria: - 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
|Official title||Extracorporeal Shock Wave Lithotriptor Indicated for Fragmenting Urinary Stones in the Kidney (Renal Pelvis)|
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