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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05835323
Recruitment Status : Completed
First Posted : April 28, 2023
Last Update Posted : January 5, 2024
Sponsor:
Information provided by (Responsible Party):
Auris Health, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Kidney Calculi Device: Robotic-assisted mini-PCNL Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Initial Experience of the Treatment of Kidney Stones With the MONARCH™ Platform, Urology
Actual Study Start Date : January 11, 2023
Actual Primary Completion Date : September 25, 2023
Actual Study Completion Date : November 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones

Arms and Interventions
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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).


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05835323


Locations
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United States, California
University of California - Irvine Medical Center
Orange, California, United States, 92868
Sponsors and Collaborators
Auris Health, Inc.
Investigators
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Principal Investigator: Jaime Landman, MD University of California, Irvine
More Information
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Responsible Party: Auris Health, Inc.
ClinicalTrials.gov Identifier: NCT05835323    
Other Study ID Numbers: 2021-URO-0001
2021-URO-0001 ( Other Identifier: Auris Health, Inc. )
First Posted: April 28, 2023    Key Record Dates
Last Update Posted: January 5, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Auris Health, Inc.:
Nephrolithotomy, Percutaneous, Ureteroscopy, Robotic, Monarch, Kidney Calculi
Additional relevant MeSH terms:
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Kidney Calculi
Nephrolithiasis
Calculi
Kidney Diseases
Urologic Diseases
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Urolithiasis
Urinary Calculi
Male Urogenital Diseases
Pathological Conditions, Anatomical