Kidney Calculi
Conditions
Keywords
Nephrolithotomy, Percutaneous, Ureteroscopy, Robotic, Monarch, Kidney Calculi
Brief summary
The purpose of the study is to assess procedural completion, the post-operative stone clearance and the safety profile following robotic mini-Percutaneous Nephrolithotomy (PCNL) performed with the MONARCH Platform, Urology.
Interventions
This robotically enabled hybrid procedure called the MONARCH Mini-PCNL will allow the clinician to obtain retrograde and percutaneous access to participant's kidney under continuous visualization for therapeutic applications (i.e., stone removal).
Sponsors
Auris Health, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
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) with stone burden =\> 1 cm, identified on CT scan, and appropriate for PCNL treatment according to AUA guidelines * Normal upper tract anatomy, amenable to PCNL and ureteroscopy * Participants with a percutaneous tract length \< 15 cm 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.
Exclusion criteria
Pre-Procedure:
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved Successful Completion of Robotic-Assisted Combined Intrarenal Surgery (RACIRS) Kidney Stone Removal Procedure | On the day of procedure at Day 1 | Percentage of participants who achieved successful completion of the RACIRS kidney stone removal procedure were reported. Successful completion of the robotic-assisted kidney stone removal procedure was defined as using robotic-assistance provided by the MONARCH Platform, Urology to achieve the following procedure milestones: (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, (4) evacuated stone fragments and dust, and (5) completed treatment without need for case conversion, as assessed by the investigator. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stone Free Rate | Post-operative Day 30 | Stone free rate was computed as the percentage of participants who were stone free assessed by computed tomography (CT) scan at post-operative Day 30. Stone free was defined as having less than or equal to (\<=) 4 millimeters (mm) residual stones detected by CT. |
| Number of Participants With Adverse Events (AEs) | From the day of procedure (Day 1) up to 90 days post-procedure | AEs were defined as any undesirable clinical occurrence in a participant, whether or not it is considered to be device-related. Adverse events were graded using the Clavien-Dindo classification system. Clavien-Dindo consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). The introduction of the subclasses a and b allows a contraction of the classification into 5 grades (I, II, III, IV and V) depending on the size of the population. Grade I to II included deviations from normal recovery requiring minimal or pharmacologic treatment. Grade III to IV involved surgical/endoscopic/radiologic interventions or life-threatening complications, with subgrades based on anesthesia and organ dysfunction. Grade V represented death of the participant. |
| Percentage of Participants With Procedure Conversions to Conventional Treatment Methods Due to Study Device-related Safety Event | On the day of procedure (Day 1) | Percentage of participants with procedures converted to conventional stone removal procedures (for example, ureteroscopy or percutaneous nephrolithotomy) due to the occurrence of a study device-related safety event was reported. A qualifying safety event was a study device-related adverse event that occurred during the study procedure, which prompted the physician to abort the study procedure, and pursue a conventional stone removal procedure. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMargaret A. Knoedler, MD
University of Wisconsin, Madison
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 57.6 Years STANDARD_DEVIATION 11.13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Number of Participants With Stone 1 Stone | 5 Participants |
| Number of Participants With Stone 2 Stones | 4 Participants |
| Number of Participants With Stone 3 Stones | 2 Participants |
| Number of Participants With Stone 4 Stones | 1 Participants |
| Number of Participants With Stone 6 Stones | 2 Participants |
| Number of Participants With Stone 7 Stones | 1 Participants |
| Participant-Level Pre-operative Linear Stone Burden | 35.1 Millimeters (mm) STANDARD_DEVIATION 18.01 |
| Participant-Level Pre-operative Stone Volume | 2959.3 Millimeter cube (mm^3) STANDARD_DEVIATION 2246 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 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 | 14 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 13 / 15 |
| serious Total, serious adverse events | 1 / 15 |
Outcome results
None listed