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

Inclusion Criteria:

• Simple renal caliceal and/or pyelo stone(s), greater than or equal to (>=) 10millimeter in size identified on computerized tomography (CT) scan, and appropriatefor Percutaneous nephrolithotomy (PCNL) treatment according to American UrologicalAssociation (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 theestimation of the skin to stone or skin to appropriate calyx for treatment through aCT scan

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

Pre-Operative Exclusion Criteria:

• Any medical or physical condition/limitation that would contraindicate aconventional ureteroscopy or PCNL [for example, atypical interposition of visceralorgans (bowel, spleen, or liver)] in the supine position. This assessment will bemade by the investigator team

• Participation in any other clinical trial 30-days before and throughout the durationof the study that might impact the results

• A solitary functioning kidney

• Female subjects who are pregnant or nursing or those of childbearing potentialrefusing 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 theinvestigator would make participating in this study not in the participant's bestinterest. For example, participants no longer considered good candidates for amini-PCNL procedure for the removal of the kidney stones.