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

NCT05835323 | Completed Results FDA Device

• 1 other identifier: 2021-URO-0001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Keywords

Nephrolithotomy, Percutaneous, Ureteroscopy, Robotic, Monarch, Kidney Calculi

Outcome Measures

Primary Outcomes (1)

• Completion of the Robotic Assisted Mini-PCNL Kidney Stone Removal Procedure.

  Percentage of participants in whom the kidney stone treatment and removal procedure could be successfully completed with the MONARCH™ Platform, Urology.

  Day of Procedure

Study Arms (1)

Robotic-assisted mini-Percutaneous Nephrolithotomy (PCNL)

EXPERIMENTAL

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.

Device: Robotic-assisted mini-PCNL

Interventions

Robotic-assisted mini-PCNL 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).

Robotic-assisted mini-Percutaneous Nephrolithotomy (PCNL)

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify 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
• \- 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.

Sponsors & Collaborators

• Auris Health, Inc.: lead

Study Sites (1)

University of California - Irvine Medical Center

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This was a single-arm, single-center, first-in-human experience with the MONARCH™ Platform, Urology in a small set of participants without a control arm. As such the generalizability of the results obtained are limited.

Results Point of Contact

• Title: Michael Schwiers
• Organization: Johnson & Johnson MedTech Surgery

mschwier@its.jnj.com

513-337-1172

Study Officials

• Jaime Landman, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: April 28, 2023
• Study Start: January 11, 2023
• Primary Completion: September 25, 2023
• Study Completion: November 1, 2023
• Last Updated: July 8, 2025
• Results First Posted: October 15, 2024

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)