Stone Access and Removal (STAR) Study
Completed · Not applicable
Conditions studied: Kidney Calculi
In brief
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.
Key facts
- Study ID
- NCT06330701
- Run by
- Auris Health, Inc.
- People needed
- 15
- Starts
- 2024-01-18
- Expected to finish
- 2025-03-11
- Last updated by the study team
- 2026-02-18
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Indiana University — Indianapolis, Indiana, United States
- UW School of Medicine and Public Health — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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