This is a single arm, multi-center study to assess the safety and efficacy of a form of extracorporeal lithotripsy, called the Enhanced Lithotripsy System, to treat urinary stones.
This is a single arm, multi-center study to assess the safety and efficacy of a form of extracorporeal lithotripsy, called the Enhanced Lithotripsy System, to treat urinary stones. Subjects will be treated up to 2 times with the Enhanced Lithotripsy System and followed for 90 days after the last treatment session.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
13
Stone treatment with the Enhanced Lithotripsy System
McArthur Urology
Campbelltown, New South Wales, Australia
Westmead Private Hospital
Westmead, New South Wales, Australia
Goldfields Urology
Bendigo, Victoria, Australia
Austin Health
Melbourne, Victoria, Australia
Proportion of study participants with Serious Device and/or Serious Procedure-Related Adverse Events (Safety)
Incidence of Serious Device and/or Serious Procedure-Related adverse events
Time frame: 90 days
Stone-free status
Proportion of study participants who are successfully treated \[absence of stones or with only clinically-insignificant remaining fragments\]
Time frame: 30 days
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