Kidney Calculi
Conditions
Keywords
Nephrolithotomy, Percutaneous, Ureteroscopy, Robotic, Monarch, Kidney Calculi
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.
Interventions
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).
Sponsors
Auris Health, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion of the Robotic Assisted Mini-PCNL Kidney Stone Removal Procedure. | Day of Procedure | Percentage of participants in whom the kidney stone treatment and removal procedure could be successfully completed with the MONARCH™ Platform, Urology. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
This was a single-arm study where all participants received treatment with the MONARCH™ Platform, Urology system.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 13 |
| 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. | 32 |
| Total | 45 |
Baseline characteristics
| Characteristic | Robotic Mini-PCNL |
|---|---|
| Age, Continuous | 60.8 Years STANDARD_DEVIATION 11.22 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 13 |
| other Total, other adverse events | 2 / 13 |
| serious Total, serious adverse events | 1 / 13 |
Outcome results
Primary
Completion of the Robotic Assisted Mini-PCNL Kidney Stone Removal Procedure.
Percentage of participants in whom the kidney stone treatment and removal procedure could be successfully completed with the MONARCH™ Platform, Urology.
Time frame: Day of Procedure
Population: All 13 participants who started the study and were treated with MONARCH™ Platform, Urology.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Robotic Mini-PCNL | Completion of the Robotic Assisted Mini-PCNL Kidney Stone Removal Procedure. | 12 Participants |