Stone Access and Removal (STAR) Study

Post-Operative Outcomes Following the Treatment of Kidney Stones With the MONARCH Platform, Urology

The purpose of the study is to assess procedural completion, the post-operative stone clearance and the safety profile following robotic mini-Percutaneous Nephrolithotomy (PCNL) performed with the MONARCH Platform, Urology.

Inclusion Criteria:

• Simple renal caliceal and/or pyelo stone(s) with stone burden => 1 cm, identified on CT scan, and appropriate for PCNL treatment according to AUA guidelines
• Normal upper tract anatomy, amenable to PCNL and ureteroscopy
• Participants with a percutaneous tract length < 15 cm 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.

Exclusion Criteria:

Pre-Procedure:Exclusion Criteria:

• Any medical or physical condition/limitation that would contra-indicate a conventional ureteroscopy or PCNL in the supine position (e.g., atypical interposition of visceral organs (bowel, spleen, or liver))
• Expected additional procedure, or participation in any clinical trial, from 30 days prior to the study procedure and throughout the duration of the study, which might impact this study's results
• A solitary functioning kidney
• Female participants who are pregnant or nursing or those of child-bearing potential refusing a pregnancy test
• Presence of ureteral impacted stones

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.