An interventional study of Robotic-assisted mini-PCNL in Kidney Calculi, sponsored by Auris Health, Inc.. Completed at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2025-07-08.
Sponsored by Auris Health, Inc. (part of Johnson & Johnson) · Not applicable, Interventional, and Treatment
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 11 that started in 2023, is one of 113 with no phase, and was the 145th 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.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
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. 11 started in 2023.
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 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.
Inclusion Criteria:
Pre-Operative 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. For example, participants no longer considered good candidates for a mini-PCNL procedure for the removal of the kidney stones.
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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 for visualization and access to the urinary tract for diagnostic and therapeutic procedures.
Device: Robotic-assisted mini-PCNL
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).
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
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.
| Milestone | Robotic Mini-PCNL |
|---|---|
| Started | 13 |
| Completed | 13 |
| Not completed | 0 |
Percentage of participants in whom the kidney stone treatment and removal procedure could be successfully completed with the MONARCH™ Platform, Urology.
| Participants | Robotic Mini-PCNL |
|---|---|
| Completion of the Robotic Assisted Mini-PCNL Kidney Stone Removal Procedure. | 12 |
Collected over 30 days post stone removal procedure. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Robotic Mini-PCNL | 0/13 (0%) | 1/13 (7.7%) | 2/13 (15.4%) |
| Event | Robotic Mini-PCNL |
|---|---|
| BacteraemiaInfections and infestations | 1/13 |
| Event | Robotic Mini-PCNL |
|---|---|
| Urinary tract infectionInfections and infestations | 1/13 |
| Ureteric injuryInjury, poisoning and procedural complications | 1/13 |
All 13 participants who started the study are included in all summaries of baseline characteristics, outcome measures and adverse events.
| Age, Continuous(Years) | Robotic Mini-PCNL |
|---|---|
| Mean | 60.8 ± 11.22 |
| Sex: Female, Male(Participants) | Robotic Mini-PCNL |
|---|---|
| Female | 6 |
| Male | 7 |
| Race (NIH/OMB)(Participants) | Robotic Mini-PCNL |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 11 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2023 to primary completion in Sep 2023, 8 months.
Results were first posted in Oct 2024, 1 year 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 8 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 Jul 2025. You cannot join it, but the record below documents what was studied.
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