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

NCT ID: NCT05835323

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-11
• Study Completion Date: 2023-11-01

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.

Conditions

Kidney Calculi

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Robotic-assisted mini-Percutaneous Nephrolithotomy (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.

Group Type: EXPERIMENTAL

Robotic-assisted mini-PCNL

Intervention Type: DEVICE

Eligible participants will be enrolled to undergo robotic-assisted PCNL using the MONARCH Platform, Urology for the removal of kidney stones. The MONARCH Platform, Urology is a novel flexible robotic device that enables the clinician to obtain both transurethral and percutaneous access to a participant's kidney under continuous visualization for therapeutic application (for example, stone removal).

Interventions

Robotic-assisted mini-PCNL

Eligible participants will be enrolled to undergo robotic-assisted PCNL using the MONARCH Platform, Urology for the removal of kidney stones. The MONARCH Platform, Urology is a novel flexible robotic device that enables the clinician to obtain both transurethral and percutaneous access to a participant's kidney under continuous visualization for therapeutic application (for example, stone removal).

Intervention Type: DEVICE

Eligibility Criteria

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

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

• 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.

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Auris Health, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jaime Landman, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

University of California - Irvine Medical Center

Orange, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2021-URO-0001

Identifier Type: OTHER

Identifier Source: secondary_id

2021-URO-0001

Identifier Type: -

Identifier Source: org_study_id