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

Recruiting in Palo Alto (17 mi)

Overseen byJaime Landman, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Auris Health, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Inclusion Criteria

Your body mass index (BMI) is less than 40, which means you are not extremely overweight.

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

+2 more

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Robotic-assisted mini-Percutaneous Nephrolithotomy (PCNL)Experimental Treatment1 Intervention

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.