for people ages 22 years and up (full criteria)
at Orange, California
study started
estimated completion
Principal Investigator
by Jaime Landman, MD



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.

Official Title

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


Kidney Calculi, Nephrolithotomy, Percutaneous, Ureteroscopy, Robotic, Monarch, Kidney Calculi, Nephrolithiasis, Calculi, Robotic-assisted mini-PCNL, Robotic-assisted mini-Percutaneous Nephrolithotomy (PCNL)


You can join if…

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


You CAN'T join if...

  • 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.


  • University of California - Irvine Medical Center accepting new patients
    Orange California 92868 United States

Lead Scientist at UC Irvine

  • Jaime Landman, MD
    Professor, Urology, School of Medicine. Authored (or co-authored) 307 research publications


accepting new patients
Start Date
Completion Date
Auris Health, Inc.
Study Type
Expecting 20 study participants
Last Updated