Stone Access and Removal (STAR) Study (STAR)

January 30, 2026 updated by: Auris Health, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • UW School of Medicine and Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Robotic mini-Percutaneous Nephrolithotomy (PCNL)
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
On the day of procedure at Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stone Free Rate
Time Frame: Post-operative Day 30
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.
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
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.
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)
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.
On the day of procedure (Day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Auris Health, Inc.

Investigators

  • Principal Investigator: Margaret A. Knoedler, MD, University of Wisconsin, Madison

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2024

Primary Completion (Actual)

December 23, 2024

Study Completion (Actual)

March 11, 2025

Study Registration Dates

First Submitted

March 19, 2024

First Submitted That Met QC Criteria

March 19, 2024

First Posted (Actual)

March 26, 2024

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

January 30, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023URO0001 (Other Identifier: Auris Health,Inc.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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