Study of an Enhanced Lithotripsy System (ELS) in the Treatment of Urinary Stone Disease

Exclusion Criteria

• •1. Age less than 18 years of age or over 75 years of age
• •2. Diagnosis of radiolucent stones
• •3. History of cystinuria
• •4. Urine pH below 5.5
• •5. Current untreated urinary tract infection
• •6. Pregnancy
• •7. Vulnerable individuals (mentally disabled, physically disabled, prisoner, etc.)
• •8. Enrollment in another research study or previous participation within 30 days of enrollment.
• •9. Participant has planned general anesthesia during index procedure with American Society of Anesthesiologists (ASA) physical classification level of 3 or greater
• •10. Known sensitivity to possible medications used before, during, or after the ELS procedure, including but not limited to the following: sedative agents, general anaesthetics, topical anaesthetics, and opioid analgesics
• •11. Coagulation abnormality or taking prescription anticoagulants that cannot be stopped during treatment. Aspirin usage will be discontinued at least 7 days prior to enrollment at the discretion of the attending physician
• •12. Mobility issues - unable to comfortably lie still for up to 120 minutes or unable to roll from back to side
• •13. Known hypersensitivity to conductivity gel
• •14. Body mass index (BMI) ≥ 35 unless anticipated skin to stone distance (anticipated distance from site of ELS treatment head to stone per pre-operative CT) is \<135mm
• •15. Implanted spinal cord neurostimulator intrathecal pump or any device that may interfere with energy transmission
• •16. Participant has open wounds, lesions, dermatitis, or ischemic tissues in the treatment area
• •17. Participant has had a major surgery that removed tissue around the spinal cord (e.g. a laminectomy) within the treatment area
• •18. Participant will undergo treatment of a stone located in the distal ureter and has previous hernia repair or surgical mesh implanted in the inguinal/hypogastric regions