Trial Outcomes & Findings for Initial Clinical Experience With the MONARCH Platform, Urology for the Treatment of Kidney Stones (NCT NCT05835323)
NCT ID: NCT05835323
Last Updated: 2025-07-08
Results Overview
Percentage of participants in whom the kidney stone treatment and removal procedure could be successfully completed with the MONARCH™ Platform, Urology.
COMPLETED
NA
15 participants
Day of Procedure
2025-07-08
Participant Flow
Participants aged 22 years or older with simple renal caliceal and/or pyelo stone(s), greater than or equal to 10 millimeters in size identified on computed tomography scan, and appropriate for percutaneous nephrolithotomy (PCNL) treatment according to American Urological Association guidelines were considered for the study. Participants were given the Informed Consent Form to read, ask questions, and sign prior to any study procedures being performed or data being collected.
This was a single-arm study where all participants received treatment with the MONARCH™ Platform, Urology system.
Unit of analysis: Kidney stones
Participant milestones
| Measure |
Robotic Mini-PCNL
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.
|
|---|---|
|
Overall Study
STARTED
|
13 32
|
|
Overall Study
COMPLETED
|
13 32
|
|
Overall Study
NOT COMPLETED
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Initial Clinical Experience With the MONARCH Platform, Urology for the Treatment of Kidney Stones
Baseline characteristics by cohort
| Measure |
Robotic Mini-PCNL
n=32 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.
|
|---|---|
|
Age, Continuous
|
60.8 Years
STANDARD_DEVIATION 11.22 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day of ProcedurePopulation: All 13 participants who started the study and were treated with MONARCH™ Platform, Urology.
Percentage of participants in whom the kidney stone treatment and removal procedure could be successfully completed with the MONARCH™ Platform, Urology.
Outcome measures
| Measure |
Robotic Mini-PCNL
n=13 Participants
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.
|
|---|---|
|
Completion of the Robotic Assisted Mini-PCNL Kidney Stone Removal Procedure.
|
12 Participants
|
Adverse Events
Robotic Mini-PCNL
Serious adverse events
| Measure |
Robotic Mini-PCNL
n=13 participants at risk
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.
|
|---|---|
|
Infections and infestations
Bacteraemia
|
7.7%
1/13 • Number of events 1 • 30 days post stone removal procedure
An adverse event (AE) is defined as any undesirable clinical occurrence in a patient whether or not it is considered to be device related. In addition, the definition of AE applies to any event with an onset post study procedure or to any underlying diseases, present at baseline, that exacerbate in severity post study procedure. All reported AEs must be recorded in the database.
|
Other adverse events
| Measure |
Robotic Mini-PCNL
n=13 participants at risk
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.
|
|---|---|
|
Infections and infestations
Urinary tract infection
|
7.7%
1/13 • Number of events 1 • 30 days post stone removal procedure
An adverse event (AE) is defined as any undesirable clinical occurrence in a patient whether or not it is considered to be device related. In addition, the definition of AE applies to any event with an onset post study procedure or to any underlying diseases, present at baseline, that exacerbate in severity post study procedure. All reported AEs must be recorded in the database.
|
|
Injury, poisoning and procedural complications
Ureteric injury
|
7.7%
1/13 • Number of events 1 • 30 days post stone removal procedure
An adverse event (AE) is defined as any undesirable clinical occurrence in a patient whether or not it is considered to be device related. In addition, the definition of AE applies to any event with an onset post study procedure or to any underlying diseases, present at baseline, that exacerbate in severity post study procedure. All reported AEs must be recorded in the database.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Principal Investigator(s) may publish or present the Study results with prior consent of the Sponsor but will not disclose confidential information. Prior to submission by a Principal Investigator for publication or presentation, the Sponsor will be provided with the opportunity to review the submission for confidential information and accuracy.
- Publication restrictions are in place
Restriction type: OTHER