This is a single arm, single 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, single 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 30 days after the last treatment session.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
3
The Enhanced Lithotripsy System is a type of lithotripsy system comprising a console, treatment head, and Acoustic Energy Focusing material. Operation of the Enhanced Lithotripsy System entails combined action of extracorporeal insonation and Acoustic Energy Focusing material to fragment urinary stones.
Muljibhai Patel Urological Hospital
Nadiād, Gujarat, India
Proportion of subjects with serious device-related adverse events (safety)
Safety: Proportion of subjects with serious device-related adverse events
Time frame: 30 days after last treatment session
Successful treatment of urinary stone
Proportion of subjects with successful treatment or urinary stone
Time frame: 14 days after last treatment session
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