Trial Outcomes & Findings for Stone Access and Removal (STAR) Study (NCT NCT06330701)
NCT ID: NCT06330701
Last Updated: 2026-02-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
On the day of procedure at Day 1
Results posted on
2026-02-18
Participant Flow
Participant milestones
| Measure |
Robotic Assisted Combined Intrarenal Surgery (RACIRS)
Participants with kidney stones were enrolled for a RACIRS procedure using the MONARCH Platform, Urology system for removal of kidney stones. Participants were then followed up to 90 days post-procedure. The MONARCH Platform, Urology enabled electro-mechanical articulation and precise control of a flexible ureteroscope and/or a flexible suction catheter for visualization and access to the urinary tract for diagnostic and therapeutic procedures.
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|---|---|
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Overall Study
STARTED
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15
|
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Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Robotic Assisted Combined Intrarenal Surgery (RACIRS)
Participants with kidney stones were enrolled for a RACIRS procedure using the MONARCH Platform, Urology system for removal of kidney stones. Participants were then followed up to 90 days post-procedure. The MONARCH Platform, Urology enabled electro-mechanical articulation and precise control of a flexible ureteroscope and/or a flexible suction catheter for visualization and access to the urinary tract for diagnostic and therapeutic procedures.
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|---|---|
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Overall Study
Withdrawal by Subject
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2
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Full analysis set included the set of participants in whom the MONARCH system was utilized during the procedure.
Baseline characteristics by cohort
| Measure |
Robotic Assisted Combined Intrarenal Surgery (RACIRS)
n=15 Participants
Participants with kidney stones were enrolled for a RACIRS procedure using the MONARCH Platform, Urology system for removal of kidney stones. Participants were then followed up to 90 days post-procedure. The MONARCH Platform, Urology enabled electro-mechanical articulation and precise control of a flexible ureteroscope and/or a flexible suction catheter for visualization and access to the urinary tract for diagnostic and therapeutic procedures.
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|---|---|
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Age, Continuous
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57.6 Years
STANDARD_DEVIATION 11.13 • n=4 Participants
|
|
Sex: Female, Male
Female
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5 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
|
Number of Participants With Stone
1 Stone
|
5 Participants
n=4 Participants • Full analysis set included the set of participants in whom the MONARCH system was utilized during the procedure.
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|
Number of Participants With Stone
2 Stones
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4 Participants
n=4 Participants • Full analysis set included the set of participants in whom the MONARCH system was utilized during the procedure.
|
|
Number of Participants With Stone
3 Stones
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2 Participants
n=4 Participants • Full analysis set included the set of participants in whom the MONARCH system was utilized during the procedure.
|
|
Number of Participants With Stone
4 Stones
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1 Participants
n=4 Participants • Full analysis set included the set of participants in whom the MONARCH system was utilized during the procedure.
|
|
Number of Participants With Stone
6 Stones
|
2 Participants
n=4 Participants • Full analysis set included the set of participants in whom the MONARCH system was utilized during the procedure.
|
|
Number of Participants With Stone
7 Stones
|
1 Participants
n=4 Participants • Full analysis set included the set of participants in whom the MONARCH system was utilized during the procedure.
|
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Participant-Level Pre-operative Linear Stone Burden
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35.1 Millimeters (mm)
STANDARD_DEVIATION 18.01 • n=4 Participants • Full analysis set included the set of participants in whom the MONARCH system was utilized during the procedure.
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Participant-Level Pre-operative Stone Volume
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2959.3 Millimeter cube (mm^3)
STANDARD_DEVIATION 2246.0 • n=4 Participants • Full analysis set included the set of participants in whom the MONARCH system was utilized during the procedure.
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PRIMARY outcome
Timeframe: On the day of procedure at Day 1Population: Full analysis set included the set of participants in whom the MONARCH system was utilized during the procedure.
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.
Outcome measures
| Measure |
Robotic Assisted Combined Intrarenal Surgery (RACIRS)
n=15 Participants
Participants with kidney stones were enrolled for a RACIRS procedure using the MONARCH Platform, Urology system for removal of kidney stones. Participants were then followed up to 90 days post-procedure. The MONARCH Platform, Urology enabled electro-mechanical articulation and precise control of a flexible ureteroscope and/or a flexible suction catheter for visualization and access to the urinary tract for diagnostic and therapeutic procedures.
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|---|---|
|
Percentage of Participants Who Achieved Successful Completion of Robotic-Assisted Combined Intrarenal Surgery (RACIRS) Kidney Stone Removal Procedure
Gained safe concomitant access to the upper urinary tract
|
100 percentage of participants
Interval 68.1 to 99.8
|
|
Percentage of Participants Who Achieved Successful Completion of Robotic-Assisted Combined Intrarenal Surgery (RACIRS) Kidney Stone Removal Procedure
Located and visualized kidney stones
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100 percentage of participants
|
|
Percentage of Participants Who Achieved Successful Completion of Robotic-Assisted Combined Intrarenal Surgery (RACIRS) Kidney Stone Removal Procedure
Achieved fragmentation of stones
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100 percentage of participants
|
|
Percentage of Participants Who Achieved Successful Completion of Robotic-Assisted Combined Intrarenal Surgery (RACIRS) Kidney Stone Removal Procedure
Evacuated stone fragments and dust
|
100 percentage of participants
|
|
Percentage of Participants Who Achieved Successful Completion of Robotic-Assisted Combined Intrarenal Surgery (RACIRS) Kidney Stone Removal Procedure
Complete treatment without need for case conversion, as assessed by the investigator
|
93.3 percentage of participants
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SECONDARY outcome
Timeframe: Post-operative Day 30Population: Full analysis set included the set of participants in whom the MONARCH system was utilized during the procedure. Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome.
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.
Outcome measures
| Measure |
Robotic Assisted Combined Intrarenal Surgery (RACIRS)
n=12 Participants
Participants with kidney stones were enrolled for a RACIRS procedure using the MONARCH Platform, Urology system for removal of kidney stones. Participants were then followed up to 90 days post-procedure. The MONARCH Platform, Urology enabled electro-mechanical articulation and precise control of a flexible ureteroscope and/or a flexible suction catheter for visualization and access to the urinary tract for diagnostic and therapeutic procedures.
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|---|---|
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Stone Free Rate
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50 percentage of participants
Interval 21.1 to 78.9
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SECONDARY outcome
Timeframe: From the day of procedure (Day 1) up to 90 days post-procedurePopulation: Full analysis set included the set of participants in whom the MONARCH system was utilized during the 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.
Outcome measures
| Measure |
Robotic Assisted Combined Intrarenal Surgery (RACIRS)
n=15 Participants
Participants with kidney stones were enrolled for a RACIRS procedure using the MONARCH Platform, Urology system for removal of kidney stones. Participants were then followed up to 90 days post-procedure. The MONARCH Platform, Urology enabled electro-mechanical articulation and precise control of a flexible ureteroscope and/or a flexible suction catheter for visualization and access to the urinary tract for diagnostic and therapeutic procedures.
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|---|---|
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Number of Participants With Adverse Events (AEs)
Grade I
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11 Participants
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Number of Participants With Adverse Events (AEs)
Grade II
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5 Participants
|
|
Number of Participants With Adverse Events (AEs)
Grade III
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs)
Grade IV
|
0 Participants
|
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Number of Participants With Adverse Events (AEs)
Grade V
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0 Participants
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SECONDARY outcome
Timeframe: On the day of procedure (Day 1)Population: Full analysis set included the set of participants in whom the MONARCH system was utilized during the procedure.
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.
Outcome measures
| Measure |
Robotic Assisted Combined Intrarenal Surgery (RACIRS)
n=15 Participants
Participants with kidney stones were enrolled for a RACIRS procedure using the MONARCH Platform, Urology system for removal of kidney stones. Participants were then followed up to 90 days post-procedure. The MONARCH Platform, Urology enabled electro-mechanical articulation and precise control of a flexible ureteroscope and/or a flexible suction catheter for visualization and access to the urinary tract for diagnostic and therapeutic procedures.
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|---|---|
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Percentage of Participants With Procedure Conversions to Conventional Treatment Methods Due to Study Device-related Safety Event
|
0 percentage of participants
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Adverse Events
Robotic Assisted Combined Intrarenal Surgery (RACIRS)
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Robotic Assisted Combined Intrarenal Surgery (RACIRS)
n=15 participants at risk
Participants with kidney stones were enrolled for a RACIRS procedure using the MONARCH Platform, Urology system for removal of kidney stones. Participants were then followed up to 90 days post-procedure. The MONARCH Platform, Urology enabled electro-mechanical articulation and precise control of a flexible ureteroscope and/or a flexible suction catheter for visualization and access to the urinary tract for diagnostic and therapeutic procedures.
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|---|---|
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Gastrointestinal disorders
Intra-abdominal fluid collection
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6.7%
1/15 • All cause mortality: From baseline (Day -120) up to 90 days post-procedure. For serious adverse events (SAEs) and other AEs: From day of the procedure (Day 1) up to 90 days post-procedure
Full analysis set included the set of participants in whom the MONARCH system was utilized during the procedure.
|
Other adverse events
| Measure |
Robotic Assisted Combined Intrarenal Surgery (RACIRS)
n=15 participants at risk
Participants with kidney stones were enrolled for a RACIRS procedure using the MONARCH Platform, Urology system for removal of kidney stones. Participants were then followed up to 90 days post-procedure. The MONARCH Platform, Urology enabled electro-mechanical articulation and precise control of a flexible ureteroscope and/or a flexible suction catheter for visualization and access to the urinary tract for diagnostic and therapeutic procedures.
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|---|---|
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General disorders
Injection site pain
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6.7%
1/15 • All cause mortality: From baseline (Day -120) up to 90 days post-procedure. For serious adverse events (SAEs) and other AEs: From day of the procedure (Day 1) up to 90 days post-procedure
Full analysis set included the set of participants in whom the MONARCH system was utilized during the procedure.
|
|
General disorders
Pyrexia
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6.7%
1/15 • All cause mortality: From baseline (Day -120) up to 90 days post-procedure. For serious adverse events (SAEs) and other AEs: From day of the procedure (Day 1) up to 90 days post-procedure
Full analysis set included the set of participants in whom the MONARCH system was utilized during the procedure.
|
|
Injury, poisoning and procedural complications
Head injury
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6.7%
1/15 • All cause mortality: From baseline (Day -120) up to 90 days post-procedure. For serious adverse events (SAEs) and other AEs: From day of the procedure (Day 1) up to 90 days post-procedure
Full analysis set included the set of participants in whom the MONARCH system was utilized during the procedure.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
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46.7%
7/15 • All cause mortality: From baseline (Day -120) up to 90 days post-procedure. For serious adverse events (SAEs) and other AEs: From day of the procedure (Day 1) up to 90 days post-procedure
Full analysis set included the set of participants in whom the MONARCH system was utilized during the procedure.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
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6.7%
1/15 • All cause mortality: From baseline (Day -120) up to 90 days post-procedure. For serious adverse events (SAEs) and other AEs: From day of the procedure (Day 1) up to 90 days post-procedure
Full analysis set included the set of participants in whom the MONARCH system was utilized during the procedure.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
6.7%
1/15 • All cause mortality: From baseline (Day -120) up to 90 days post-procedure. For serious adverse events (SAEs) and other AEs: From day of the procedure (Day 1) up to 90 days post-procedure
Full analysis set included the set of participants in whom the MONARCH system was utilized during the procedure.
|
|
Renal and urinary disorders
Bladder spasm
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20.0%
3/15 • All cause mortality: From baseline (Day -120) up to 90 days post-procedure. For serious adverse events (SAEs) and other AEs: From day of the procedure (Day 1) up to 90 days post-procedure
Full analysis set included the set of participants in whom the MONARCH system was utilized during the procedure.
|
|
Renal and urinary disorders
Haematuria
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20.0%
3/15 • All cause mortality: From baseline (Day -120) up to 90 days post-procedure. For serious adverse events (SAEs) and other AEs: From day of the procedure (Day 1) up to 90 days post-procedure
Full analysis set included the set of participants in whom the MONARCH system was utilized during the procedure.
|
|
Renal and urinary disorders
Dysuria
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13.3%
2/15 • All cause mortality: From baseline (Day -120) up to 90 days post-procedure. For serious adverse events (SAEs) and other AEs: From day of the procedure (Day 1) up to 90 days post-procedure
Full analysis set included the set of participants in whom the MONARCH system was utilized during the procedure.
|
|
Renal and urinary disorders
Chromaturia
|
6.7%
1/15 • All cause mortality: From baseline (Day -120) up to 90 days post-procedure. For serious adverse events (SAEs) and other AEs: From day of the procedure (Day 1) up to 90 days post-procedure
Full analysis set included the set of participants in whom the MONARCH system was utilized during the procedure.
|
|
Gastrointestinal disorders
Constipation
|
13.3%
2/15 • All cause mortality: From baseline (Day -120) up to 90 days post-procedure. For serious adverse events (SAEs) and other AEs: From day of the procedure (Day 1) up to 90 days post-procedure
Full analysis set included the set of participants in whom the MONARCH system was utilized during the procedure.
|
|
Gastrointestinal disorders
Abdominal pain
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6.7%
1/15 • All cause mortality: From baseline (Day -120) up to 90 days post-procedure. For serious adverse events (SAEs) and other AEs: From day of the procedure (Day 1) up to 90 days post-procedure
Full analysis set included the set of participants in whom the MONARCH system was utilized during the procedure.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • All cause mortality: From baseline (Day -120) up to 90 days post-procedure. For serious adverse events (SAEs) and other AEs: From day of the procedure (Day 1) up to 90 days post-procedure
Full analysis set included the set of participants in whom the MONARCH system was utilized during the procedure.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
6.7%
1/15 • All cause mortality: From baseline (Day -120) up to 90 days post-procedure. For serious adverse events (SAEs) and other AEs: From day of the procedure (Day 1) up to 90 days post-procedure
Full analysis set included the set of participants in whom the MONARCH system was utilized during the procedure.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
6.7%
1/15 • All cause mortality: From baseline (Day -120) up to 90 days post-procedure. For serious adverse events (SAEs) and other AEs: From day of the procedure (Day 1) up to 90 days post-procedure
Full analysis set included the set of participants in whom the MONARCH system was utilized during the procedure.
|
|
Reproductive system and breast disorders
Penile discomfort
|
6.7%
1/15 • All cause mortality: From baseline (Day -120) up to 90 days post-procedure. For serious adverse events (SAEs) and other AEs: From day of the procedure (Day 1) up to 90 days post-procedure
Full analysis set included the set of participants in whom the MONARCH system was utilized during the procedure.
|
|
Reproductive system and breast disorders
Penile pain
|
6.7%
1/15 • All cause mortality: From baseline (Day -120) up to 90 days post-procedure. For serious adverse events (SAEs) and other AEs: From day of the procedure (Day 1) up to 90 days post-procedure
Full analysis set included the set of participants in whom the MONARCH system was utilized during the procedure.
|
|
Infections and infestations
Fungal skin infection
|
6.7%
1/15 • All cause mortality: From baseline (Day -120) up to 90 days post-procedure. For serious adverse events (SAEs) and other AEs: From day of the procedure (Day 1) up to 90 days post-procedure
Full analysis set included the set of participants in whom the MONARCH system was utilized during the procedure.
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • All cause mortality: From baseline (Day -120) up to 90 days post-procedure. For serious adverse events (SAEs) and other AEs: From day of the procedure (Day 1) up to 90 days post-procedure
Full analysis set included the set of participants in whom the MONARCH system was utilized during the procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.7%
1/15 • All cause mortality: From baseline (Day -120) up to 90 days post-procedure. For serious adverse events (SAEs) and other AEs: From day of the procedure (Day 1) up to 90 days post-procedure
Full analysis set included the set of participants in whom the MONARCH system was utilized during the procedure.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
1/15 • All cause mortality: From baseline (Day -120) up to 90 days post-procedure. For serious adverse events (SAEs) and other AEs: From day of the procedure (Day 1) up to 90 days post-procedure
Full analysis set included the set of participants in whom the MONARCH system was utilized during the procedure.
|
|
Vascular disorders
Hypertension
|
6.7%
1/15 • All cause mortality: From baseline (Day -120) up to 90 days post-procedure. For serious adverse events (SAEs) and other AEs: From day of the procedure (Day 1) up to 90 days post-procedure
Full analysis set included the set of participants in whom the MONARCH system was utilized during the procedure.
|
Additional Information
Dir Clin Dev NonMD
Janssen Research and Development, LLC
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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