Feasibility Study of an Enhanced Lithotripsy System in the Treatment of Urinary Stone Disease

Feasibility Study of an Enhanced Lithotripsy System in the Treatment of Urinary Stone Disease

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.

Inclusion Criteria:

• Individuals presenting with one urinary stone-apparent on a computed tomography scan within the last 14 days
• Males and females aged 18 or older
• Capable of giving informed consent, and willing to have the informed consent process videotaped
• Stone size, as estimated by pre-operative computed tomography, with all dimensions 15 mm or less.

Exclusion Criteria:

• Individuals under 18 years of age
• Individuals with radiolucent stones
• Individuals with stones in the lower pole of kidney
• Individuals not following up in the treating hospital
• Individuals with history of cystinuria
• Individuals with urine pH below 5.5
• Individuals with untreated urinary tract infection
• Individuals who are not willing to use adequate method of contraception during the study period
• Women who are pregnant, lactating or planning pregnancy during the study period
• Individuals with a coagulation abnormality or taking prescription anticoagulants.
• Individuals with mobility issues who are unable to comfortably lie still for up to 30 minutes or roll from their back to their side
• Individuals belonging to a vulnerable group (pregnant, mentally disabled, physically disabled, prisoner, etc.)
• Individuals with a body mass index greater than 35
• Individuals with ASA score of 3 or greater general anesthesia risk level
• Known sensitivity to possible medications used before, during, or after the treatment procedure, including but not limited to the following: sedative agents, general anesthetics, topical anesthetics, and opioid analgesics