Evaluation of Enhanced Lithotripsy System (ELS) in the Treatment of Urinary Stones, A Pivotal Trial

Inclusion Criteria:

• Male or Female aged >=21 Years

• Provides written informed consent

• One urinary stone within the ureter, size >=5 mm and <=10 mm

• Stone is indicated for Shock Wavve Lithotrips Per AUA 2016 guidelines

• Urinary stone is present on a CT scan within past 14 days

Exclusion Criteria:

• Anatomic presentations that would preclude obtaining an acoustic window for theultrasound treatment

• Medical Expulsion Therapy (e.g., Flomax)

• Non-calcium based stones (e.g., uric acid stones)

• Untreated UTI

• Presence of abnormal skin conditions in the area to be treated

• Coagulation abnormality

• Inability to lay still for 30 minutes

• Pregnant

• Abnormal Kidney Function

• Any genitourinary history or procedure that has altered anatomy (e.g. urinary tractreconstruction)