Kidney CalculiNCT05835323

Initial Clinical Experience With the MONARCH Platform, Urology for the Treatment of Kidney Stones

A study testing Robotic-assisted mini-PCNL in people with Kidney Calculi, run by Auris Health, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 22 years and older
Conditions the study is for: Kidney Calculi
What is being tested?: Robotic-assisted mini-PCNL
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: 11 Jan 2023to 1 Nov 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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:

Show all 21Show fewer

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 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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of California - Irvine Medical Center
Orange, California, 92868

Other trials in United States

About this study

Official title: Initial Experience of the Treatment of Kidney Stones With the MONARCH™ Platform, Urology

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.

Conditions: Kidney Calculi
Being tested: Robotic-assisted mini-PCNL
Keywords: Nephrolithotomy, Percutaneous, Ureteroscopy, Robotic, Monarch, Kidney Calculi
Medical subject headings: Kidney Calculi

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Robotic-assisted mini-PCNLDevice
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).

Study groups in NCT05835323
Study group	Role	What they receive
Robotic-assisted mini-Percutaneous Nephrolithotomy (PCNL)	Experimental	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. Receives: Device: Robotic-assisted mini-PCNL

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day of Procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jan 20231 Nov 2023

First posted28 Apr 2023
Study start11 Jan 2023
Primary completion25 Sep 2023
Study completion1 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Kidney CalculiStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05835323
Sponsor's protocol ID: 2021-URO-0001
Other IDs: 2021-URO-0001
Status last verified: Jul 2025
First submitted: 18 Apr 2023
Last updated: 8 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Dexamethasone for Ureteral STent Symptoms (DUSTS)
Ureteral Stent-Related Symptom
Not yet recruitingEarly Phase 1
Phosphate & Kidney Stones
Kidney Stones, Calcium Oxalate Kidney Stones
Recruiting
Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology
Urolithiasis, Stones, Kidney
Active, not recruitingObservational study
A Retrospective, Multi-center Real-world Study of Steerable Ureteroscopic Renal Evacuation (SURE) Procedure With the CVAC® System
Urolithiasis, Kidney Stone
Recruiting
Supervised Endoscopic Tele-controlled Intelligent Lithotripsy
Renal Stone

All Kidney Calculi trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Initial Experience of the Treatment of Kidney Stones With the MONARCH™ Platform, Urology
ClinicalTrials.gov ID: NCT05835323
Acronym / sponsor ID: 2021-URO-0001
Conditions: Kidney Calculi
Keywords: Nephrolithotomy, Percutaneous, Ureteroscopy, Robotic, Monarch, Kidney Calculi
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Auris Health, Inc.Industry (pharma, biotech, devices)
Study start: 11 Jan 2023 (actual)
Primary completion: 25 Sep 2023 (actual)
Study completion: 1 Nov 2023 (actual)
First posted: 28 Apr 2023 (actual)
Results: Posted 15 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Robotic-assisted mini-Percutaneous Nephrolithotomy (PCNL)	Experimental	Device: Robotic-assisted mini-PCNLParticipants 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.

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (21 listed)

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

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Robotic-assisted mini-PCNLEligible 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).	Device	Robotic-assisted mini-Percutaneous Nephrolithotomy (PCNL)

Primary outcome

Completion of the Robotic Assisted Mini-PCNL Kidney Stone Removal Procedure.
Time frame: Day of Procedure
Percentage of participants in whom the kidney stone treatment and removal procedure could be successfully completed with the MONARCH™ Platform, Urology.

Results and safety

Results posted to the registry on 15 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Robotic Mini-PCNL	13	13

Primary outcome: Completion of the Robotic Assisted Mini-PCNL Kidney Stone Removal Procedure.

Time frame: Day of Procedure. Count of participants. Unit: Participants

Measure	Robotic Mini-PCNL n = 13
Value	12

Population analysed: All 13 participants who started the study and were treated with MONARCH™ Platform, Urology.

Adverse events

Time frame: 30 days post stone removal procedure. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Robotic Mini-PCNL	1 of 13 (7.7%)	2 of 13 (15.4%)	0 of 13

Limitations and caveats (from the sponsor): This was a single-arm, single-center, first-in-human experience with the MONARCH™ Platform, Urology in a small set of participants without a control arm. As such the generalizability of the results obtained are limited.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Kidney Calculi

RecruitingPhase 1/2
Dexamethasone for Ureteral STent Symptoms (DUSTS)
Ureteral Stent-Related Symptom
Not yet recruitingEarly Phase 1
Phosphate & Kidney Stones
Kidney Stones, Calcium Oxalate Kidney Stones
Recruiting
Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology
Urolithiasis, Stones, Kidney
Active, not recruitingObservational study
A Retrospective, Multi-center Real-world Study of Steerable Ureteroscopic Renal Evacuation (SURE) Procedure With the CVAC® System
Urolithiasis, Kidney Stone
Recruiting
Supervised Endoscopic Tele-controlled Intelligent Lithotripsy
Renal Stone

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jaime Landman, MD principal investigator

University of California, Irvine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Robotic-assisted mini-PCNL in people with Kidney Calculi, run by Auris Health, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Completion of the Robotic Assisted Mini-PCNL Kidney Stone Removal Procedure. (time frame: Day of Procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05835323.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.