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

Not Applicable

Completed

Brief Summary: The purpose of this study is to collect descriptive performance data using the MONARCH Platform, Urology (a novel robotic device) to perform mini-percutaneous nephrolithotomy (kidney stone removal) procedures. Data gathered from this study will be used to optimize the robotic platform and inform training and education material for the future users.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
Robotic-assisted mini-Percutaneous Nephrolithotomy (PCNL)	Robotic-assisted mini-PCNL	Participants with kidney stones will be enrolled for robotic-assisted mini-percutaneous nephrolithotomy procedure using the MONARCH Platform, Urology for removal of kidney stones. The MONARCH Platform, Urology enables electro-mechanical articulation and precise control of a flexible ureteroscope and/or a flexible mini-PCNL suction catheter for visualization and access to the urinary tract for diagnostic and therapeutic procedures.

Primary Outcome Measures

Name	Time	Method
Completion of the Robotic Assisted Mini-PCNL Kidney Stone Removal Procedure.	Day of Procedure	Percentage of participants in whom the kidney stone treatment and removal procedure could be successfully completed with the MONARCH™ Platform, Urology.

Secondary Outcome Measures