An interventional study of Robotic-assisted mini-PCNL in Kidney Calculi, sponsored by Auris Health, Inc.. Completed at 2 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-02-18.
Sponsored by Auris Health, Inc. (part of Johnson & Johnson) · Not applicable, Interventional, and Other
Among 193 studies in Kidney Calculi with a site in United States — 42 open to participants now, 58 under way, none of them phase 3. Kidney Calculi · United States.
Among the 193 studies in Kidney Calculi with a site in United States, this one is the 125th largest by enrollment of the 165 interventional ones that give a count, is one of 13 that started in 2024, is one of 113 with no phase, and was the 153rd registered.
509 studies on the registry are indexed under Kidney Calculi; 146 are open to participants now.
Browse Kidney Calculi studies →42 of the 193 studies in Kidney Calculi with a site in United States are open now. Recruiting first, the newest first:
Calyxo, Inc. · Sites in United States
Ages 18+
YolTech Therapeutics Co., Ltd · Sites in United States
Ages 6+
Children's Hospital of Philadelphia · Sites in United States
Ages 6+
Ohio State University · Sites in United States
Ages 18+
Calyxo, Inc. · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 88 Kidney Calculi studies recruiting now, 48 (55%) set no upper age limit and 23 (26%) stop at 75 or younger; 6 take children under 18; 11 take healthy volunteers.
This study: 22 Years and older · all sexes · no healthy volunteers.
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193 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 14 · Phase 2 23 · Phase 3 9 · Phase 4 13
First in 1998; this study’s year is marked. 13 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 15 is below the median of 86 across 391 interventional studies indexed under Kidney Calculi.
Median enrollment 47 across the 165 interventional studies, 122 across the 28 observational. Of the 116 that completed or were terminated, 51 (44%) have results posted.
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34 of 193 have an industry lead sponsor. The 10 most frequent:
This study is registered under Auris Health, Inc., one of the names counted as Johnson & Johnson. Under that name alone:
Auris Health, Inc. is the lead sponsor of 8 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 4 (67%) have results posted.
Johnson & Johnson has 2 studies filed under Kidney Calculi — fewer than ten, so there is no comparison to draw.
17 of the studies in Kidney Calculi with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07296835University of Kansas Medical CenterSurgical Outcomes and Costs in Using the Shenzhen HugeMed 6.3 French Flexible Ureteroscope | 2026-11 |
| NCT04651088University of Texas Southwestern Medical CenterComparing Alkalinizing Agents Efficacy on Stone Risk in Patients on a Metabolically Controlled Diet | 2026-12 |
| NCT05993546The Cleveland ClinicRandomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis | 2026-12 |
| NCT04333745University of Alabama at BirminghamInfluence of Obesity on Oxalate Metabolism and Handling in Calcium Oxalate Stone Formers | 2026-12-01 |
| NCT04603898University of Alabama at BirminghamOxalate Formation From Ascorbic Acid | 2026-12-01 |
Add all 17 to your calendar (.ics) → With an account.
Among the 193 studies in Kidney Calculi with a site in United States, from their registry updates:
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Pre-Procedure:Exclusion Criteria:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with kidney stones will be enrolled for a robotic-assisted mini-percutaneous nephrolithotomy procedure using the MONARCH Platform, Urology for removal of 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 ("catheter") for visualization and access to the urinary tract for diagnostic and therapeutic procedures.
Device: Robotic-assisted mini-PCNL
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).
Percentage of Participants Who Achieved Successful Completion of Robotic-Assisted Combined Intrarenal Surgery (RACIRS) Kidney Stone Removal 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.
Time frame: On the day of procedure at Day 1
Stone Free Rate
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.
Time frame: Post-operative Day 30
Number of Participants With Adverse Events (AEs)
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.
Time frame: From the day of procedure (Day 1) up to 90 days post-procedure
Percentage of Participants With Procedure Conversions to Conventional Treatment Methods Due to Study Device-related Safety Event
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.
Time frame: On the day of procedure (Day 1)
| Milestone | Robotic Assisted Combined Intrarenal Surgery (RACIRS) |
|---|---|
| Started | 15 |
| Completed | 12 |
| Not completed | 3 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Lost to follow-up | 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.
| percentage of participants | Robotic Assisted Combined Intrarenal Surgery (RACIRS) |
|---|---|
| Gained safe concomitant access to the upper urinary tract | 100 (68.1 to 99.8) |
| Located and visualized kidney stones | 100 |
| Achieved fragmentation of stones | 100 |
| Evacuated stone fragments and dust | 100 |
| Complete treatment without need for case conversion, as assessed by the investigator | 93.3 |
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.
| percentage of participants | Robotic Assisted Combined Intrarenal Surgery (RACIRS) |
|---|---|
| Stone Free Rate | 50 (21.1 to 78.9) |
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.
| Participants | Robotic Assisted Combined Intrarenal Surgery (RACIRS) |
|---|---|
| Grade I | 11 |
| Grade II | 5 |
| Grade III | 1 |
| Grade IV | 0 |
| Grade V | 0 |
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.
| percentage of participants | Robotic Assisted Combined Intrarenal Surgery (RACIRS) |
|---|---|
| Percentage of Participants With Procedure Conversions to Conventional Treatment Methods Due to Study Device-related Safety Event | 0 |
Collected over 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. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Robotic Assisted Combined Intrarenal Surgery (RACIRS) | 0/15 (0%) | 1/15 (6.7%) | 13/15 (86.7%) |
| Event | Robotic Assisted Combined Intrarenal Surgery (RACIRS) |
|---|---|
| Intra-abdominal fluid collectionGastrointestinal disorders | 1/15 |
| Event | Robotic Assisted Combined Intrarenal Surgery (RACIRS) |
|---|---|
| Flank painMusculoskeletal and connective tissue disorders | 7/15 |
| Bladder spasmRenal and urinary disorders | 3/15 |
| HaematuriaRenal and urinary disorders | 3/15 |
| DysuriaRenal and urinary disorders | 2/15 |
| ConstipationGastrointestinal disorders | 2/15 |
| Muscle spasmsMusculoskeletal and connective tissue disorders | 1/15 |
| Musculoskeletal discomfortMusculoskeletal and connective tissue disorders | 1/15 |
| ChromaturiaRenal and urinary disorders | 1/15 |
| Abdominal painGastrointestinal disorders | 1/15 |
| NauseaGastrointestinal disorders | 1/15 |
| Age, Continuous(Years) | Robotic Assisted Combined Intrarenal Surgery (RACIRS) |
|---|---|
| Mean | 57.6 ± 11.13 |
| Sex: Female, Male(Participants) | Robotic Assisted Combined Intrarenal Surgery (RACIRS) |
|---|---|
| Female | 5 |
| Male | 10 |
| Ethnicity (NIH/OMB)(Participants) | Robotic Assisted Combined Intrarenal Surgery (RACIRS) |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 15 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Robotic Assisted Combined Intrarenal Surgery (RACIRS) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 14 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Number of Participants With Stone(Participants) | Robotic Assisted Combined Intrarenal Surgery (RACIRS) |
|---|---|
| 1 Stone | 5 |
| 2 Stones | 4 |
| 3 Stones | 2 |
| 4 Stones | 1 |
| 6 Stones | 2 |
| 7 Stones | 1 |
| Participant-Level Pre-operative Linear Stone Burden(Millimeters (mm)) | Robotic Assisted Combined Intrarenal Surgery (RACIRS) |
|---|---|
| Mean | 35.1 ± 18.01 |
| Participant-Level Pre-operative Stone Volume(Millimeter cube (mm^3)) | Robotic Assisted Combined Intrarenal Surgery (RACIRS) |
|---|---|
| Mean | 2959.3 ± 2246.0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2024 to primary completion in Dec 2024, 11 months.
Results were first posted in Feb 2026, 1 year 1 month after primary completion.
Of 199 interventional studies with no phase under Kidney Calculi, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 51. This study's 11 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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