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

January 3, 2024 updated by: Auris Health, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • University of California - Irvine Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Robotic-assisted mini-Percutaneous Nephrolithotomy (PCNL) Procedures Completed
Time Frame: Procedure Visit (Day 0)
The percentage of Robotic-assisted mini-PCNL procedures that are successfully completed. Completion is defined as: (1) gained safe concomitant (that is, retrograde and antegrade) access to the upper urinary tract, (2) located and visualized kidney stones, (3) enabled fragmentation of stones by standard of care method, and (4) evacuated stone fragments and dust.
Procedure Visit (Day 0)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Adverse Events
Time Frame: Up to 30 days, Post-operative (Day 30)
Adverse events are defined as any undesirable clinical occurrence in a participant, whether or not it is considered to be device-related. All adverse events will be reported.
Up to 30 days, Post-operative (Day 30)
Number of Procedures Converted to Conventional Methods (Ureteroscopy or Percutaneous Nephrolithotomy)
Time Frame: Procedure Visit, Day 0
Number of procedures converted to conventional methods (ureteroscopy or percutaneous nephrolithotomy) for any reason will be reported.
Procedure Visit, Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Auris Health, Inc.

Investigators

  • Principal Investigator: Jaime Landman, MD, University of California, Irvine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2023

Primary Completion (Actual)

September 25, 2023

Study Completion (Actual)

November 1, 2023

Study Registration Dates

First Submitted

April 18, 2023

First Submitted That Met QC Criteria

April 18, 2023

First Posted (Actual)

April 28, 2023

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 3, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-URO-0001 (Other Identifier: Auris Health, Inc.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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