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

Multi-Center Feasibility Study of Enhanced Lithotripsy System (ELS) in The Treatment of Urinary Stone Disease

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.

Inclusion Criteria:

• Male or female aged ≥ 18 years to ≤ 75 years.
• One urinary stone-apparent on a computed tomography (CT) scan within 14 days prior to study enrollment
• Stone size, as estimated by pre-procedure CT, with all dimensions 15 mm or less.
• Provides written informed consent
• Understands and accepts the study requirements

Exclusion Criteria:

• Age less than 18 years of age or over 75 years of age
• Diagnosis of radiolucent stones
• Diagnosis of stones in the lower pole of kidney
• History of cystinuria
• Urine pH below 5.5
• Current untreated urinary tract infection
• Pregnancy
• Coagulation abnormality or taking prescription anticoagulants. Aspirin usage will be discontinued at least 7 days prior to enrollment at the discretion of the attending physician.
• Mobility issues - unable to comfortably lie still for up to 30 minutes or unable to roll from back to side
• Known hypersensitivity to conductivity gel
• Vulnerable individuals (mentally disabled, physically disabled, prisoner, etc.)
• Body mass index greater than 35
• American Society of Anesthesiologists (ASA) score of 3 or greater general anesthesia risk level
• 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.
• Enrollment in another research study or previous participation within 30 days of enrollment.