Initial Clinical Experience With the MONARCH Platform, Urology for the Treatment of Kidney Stones

Open to people ages 22 years and up

• Simple renal caliceal and/or pyelo stone(s), greater than or equal to (>=) 10 millimeter in size identified on computerized tomography (CT) scan, and appropriate for Percutaneous nephrolithotomy (PCNL) treatment according to American Urological Association (AUA) guidelines
• Normal upper tract anatomy, amenable to PCNL and ureteroscopy
• Body mass index less than (<) 40 kilogram-meter squared
• Participants with a percutaneous tract length <15 centimeter as measured by the estimation of the skin to stone or skin to appropriate calyx for treatment through a CT scan

• Participant is an appropriate candidate for a mini-PCNL based on the clinical guidelines and investigator assessment

  Pre-Operative

• Any medical or physical condition/limitation that would contraindicate a conventional ureteroscopy or PCNL [for example, atypical interposition of visceral organs (bowel, spleen, or liver)] in the supine position. This assessment will be made by the investigator team
• Participation in any other clinical trial 30-days before and throughout the duration of the study that might impact the results
• A solitary functioning kidney
• Female subjects who are pregnant or nursing or those of childbearing potential refusing a pregnancy test
• Presence of ureteral impacted stones
• Presence of ureteral obstruction
• Presence of untreated urinary tract infection, urosepsis
• Inability to give consent
• Presence of a renal mass which has not been investigated
• Staghorn stone
• Participant has an electrically or magnetically activated implanted medical device
• Significant pharmacological anticoagulant therapy or uncorrected bleeding diathesis

• Tumor in the probable access tract area and potential malignant renal tumor

  Intra-Procedure Exclusion Criteria: - Any presenting condition discovered intra procedurally that in the opinion of the investigator would make participating in this study not in the participant's best interest. For example, participants no longer considered good candidates for a mini-PCNL procedure for the removal of the kidney stones.