N/A
N=15
Stone Access and Removal (STAR) Study
Kidney Calculi
Bottom Line
View on ClinicalTrials.gov: NCT06330701 ↗Enrolled (actual)
15
Serious AEs
6.7%
Results posted
Feb 2026
Primary outcome: Primary: Percentage of Participants Who Achieved Successful Completion of Robotic-Assisted Combined Intrarenal Surgery (RACIRS) Kidney Stone Removal Procedure — 100; 100; 100; 100 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Robotic-assisted mini-PCNL (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Auris Health, Inc.
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved Successful Completion of Robotic-Assisted Combined Intrarenal Surgery (RACIRS) Kidney Stone Removal Procedure |
100; 100; 100; 100; 93.3 | — |
| SECONDARY Stone Free Rate |
50 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
11; 5; 1; 0; 0 | — |
| SECONDARY Percentage of Participants With Procedure Conversions to Conventional Treatment Methods Due to Study Device-related Safety Event |
— | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT06330701). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.