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

Primary Purpose

Kidney Calculi

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Robotic-assisted mini-PCNL
Sponsored by
Auris Health, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Calculi focused on measuring Nephrolithotomy, Percutaneous, Ureteroscopy, Robotic, Monarch, Kidney Calculi

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California - Irvine Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Robotic-assisted mini-Percutaneous Nephrolithotomy (PCNL)

Arm Description

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.

Outcomes

Primary Outcome Measures

Percentage of Robotic-assisted mini-Percutaneous Nephrolithotomy (PCNL) Procedures Completed
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

Number of Adverse Events
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.
Number of Procedures Converted to Conventional Methods (Ureteroscopy or Percutaneous Nephrolithotomy)
Number of procedures converted to conventional methods (ureteroscopy or percutaneous nephrolithotomy) for any reason will be reported.

Full Information

First Posted
April 18, 2023
Last Updated
October 10, 2023
Sponsor
Auris Health, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05835323
Brief Title
Initial Clinical Experience With the MONARCH Platform, Urology for the Treatment of Kidney Stones
Official Title
Initial Experience of the Treatment of Kidney Stones With the MONARCH™ Platform, Urology
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 11, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Auris Health, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Calculi
Keywords
Nephrolithotomy, Percutaneous, Ureteroscopy, Robotic, Monarch, Kidney Calculi

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Robotic-assisted mini-Percutaneous Nephrolithotomy (PCNL)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Robotic-assisted mini-PCNL
Intervention Description
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).
Primary Outcome Measure Information:
Title
Percentage of Robotic-assisted mini-Percutaneous Nephrolithotomy (PCNL) Procedures Completed
Description
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.
Time Frame
Procedure Visit (Day 0)
Secondary Outcome Measure Information:
Title
Number of Adverse Events
Description
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.
Time Frame
Up to 30 days, Post-operative (Day 30)
Title
Number of Procedures Converted to Conventional Methods (Ureteroscopy or Percutaneous Nephrolithotomy)
Description
Number of procedures converted to conventional methods (ureteroscopy or percutaneous nephrolithotomy) for any reason will be reported.
Time Frame
Procedure Visit, Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nancy L Sehgel, Ph.D
Phone
609-937-6963
Email
nsehgel@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaime Landman, MD
Organizational Affiliation
University of California, Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California - Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaime Landman, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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