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

Kidney Calculi Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05835323
• Other study ID #: 2021-URO-0001
• Secondary ID: 2021-URO-0001
• Status: Completed
• Phase: N/A
• Start date: January 11, 2023
• Est. completion date: November 1, 2023

Study information

• Verified date: January 2024
• Source: Auris Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 1, 2023
• Est. primary completion date: September 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Nephrolithiasis

Intervention

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).

Locations

Country	Name	City	State
United States	University of California - Irvine Medical Center	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
Auris Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Procedure Visit (Day 0)
Secondary	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.	Up to 30 days, Post-operative (Day 30)
Secondary	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.	Procedure Visit, Day 0