Kidney CalculiSTARNCT06330701
Stone Access and Removal (STAR) Study
A study testing Robotic-assisted mini-PCNL in people with Kidney Calculi, run by Auris Health, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- 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
- 2 sitesUnited States
- Study dates
- 18 Jan 2024to 11 Mar 2025
- 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) 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.
Who cannot join
- Pre-Procedure:Exclusion Criteria:
- Any medical or physical condition/limitation that would contra-indicate a conventional ureteroscopy or PCNL in the supine position (e.g., atypical interposition of visceral organs (bowel, spleen, or liver))
- Expected additional procedure, or participation in any clinical trial, from 30 days prior to the study procedure and throughout the duration of the study, which might impact this study's results
- A solitary functioning kidney
- Female participants who are pregnant or nursing or those of child-bearing potential refusing a pregnancy test
- Presence of ureteral impacted stones
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Indiana University
Indianapolis, Indiana, 46202
UW School of Medicine and Public Health
Madison, Wisconsin, 53705
About this study
Official title: Post-Operative Outcomes Following the Treatment of Kidney Stones With the MONARCH Platform, Urology
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.
- 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
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).
| Study group | Role | What they receive |
|---|---|---|
| Robotic mini-Percutaneous Nephrolithotomy (PCNL) | Experimental | 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. Receives: Device: Robotic-assisted mini-PCNL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: On the day of procedure at Day 1
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: On the day of procedure (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start18 Jan 2024
- Primary completion23 Dec 2024
- Study completion11 Mar 2025
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Auris Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Margaret A. Knoedler, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330701
- Sponsor's protocol ID
- 2023URO0001
- Other IDs
- 2023URO0001
- Acronym
- STAR
- Status last verified
- Jan 2026
- First submitted
- 19 Mar 2024
- Last updated
- 18 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Operative Outcomes Following the Treatment of Kidney Stones With the MONARCH Platform, Urology
- ClinicalTrials.gov ID
- NCT06330701
- Acronym / sponsor ID
- STAR / 2023URO0001
- 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
- 18 Jan 2024 (actual)
- Primary completion
- 23 Dec 2024 (actual)
- Study completion
- 11 Mar 2025 (actual)
- First posted
- 26 Mar 2024 (actual)
- Results
- Posted 18 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic mini-Percutaneous Nephrolithotomy (PCNL) | Experimental | Device: Robotic-assisted mini-PCNLParticipants 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- Any medical or physical condition/limitation that would contra-indicate a conventional ureteroscopy or PCNL in the supine position (e.g., atypical interposition of visceral organs (bowel, spleen, or liver))
- Expected additional procedure, or participation in any clinical trial, from 30 days prior to the study procedure and throughout the duration of the study, which might impact this study's results
- A solitary functioning kidney
- Female participants who are pregnant or nursing or those of child-bearing potential refusing a pregnancy test
- Presence of ureteral impacted stones
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-PCNLThis 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). | Device | Robotic mini-Percutaneous Nephrolithotomy (PCNL) |
Primary outcome
Percentage of Participants Who Achieved Successful Completion of Robotic-Assisted Combined Intrarenal Surgery (RACIRS) Kidney Stone Removal Procedure
Time frame: 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.
3 secondary outcomes
Stone Free Rate
Time frame: Post-operative Day 30
Number of Participants With Adverse Events (AEs)
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
Time frame: On the day of procedure (Day 1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Kidney Calculi
Recruiting
Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis
Kidney Stone
Not yet recruitingObservational study
Novel Antimicrobial Solution to Prevent Infections
Kidney Stone, Infection
Not yet recruiting
DISS vs FANS in Suction-Assisted RIRS for Medium-Sized Renal Stones
Kidney Stones, Nephrolithiasis
RecruitingPhase 3
Trial to Assess the Efficacy of EMPAgliflozin and Personalized Dietary Counseling for Kidney STONE Prevention
Kidney Stone, Nephrolithiasis
RecruitingObservational study
Renal Stone Treatment Global Registry
Urolithiasis
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.
Margaret A. Knoedler, MD principal investigator
University of Wisconsin, Madison
2 sites 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 2 sites 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 4 inclusion and 8 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 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 18 Feb 2026). 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?
Percentage of Participants Who Achieved Successful Completion of Robotic-Assisted Combined Intrarenal Surgery (RACIRS) Kidney Stone Removal Procedure (time frame: On the day of procedure at Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2026.