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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.
Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
LithoSpace Extracorporeal Shockwave Lithotripter
Metropolitan Lithotriptor Associates
Advance Shockwave Technology GmbH
Published on BioPortfolio: 2014-08-27T03:20:02-0400
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Formation of stones in the KIDNEY.
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