Stone Access and Removal (STAR) Study
- Conditions
- Kidney Calculi
- Interventions
- Device: Robotic-assisted mini-PCNL
- Registration Number
- NCT06330701
- Lead Sponsor
- Auris Health, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- 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.
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Robotic mini-Percutaneous Nephrolithotomy (PCNL) Robotic-assisted mini-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.
- Primary Outcome Measures
Name Time Method Percentage of Robotic-assisted mini-Percutaneous Nephrolithotomy (PCNL) Kidney Stone Removal Procedure Completed Procedure Visit (Day 0) The percentage of Robotic-assisted mini-PCNL procedures that are successfully completed will be reported. Completion is defined as: (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) Complete treatment without need for case conversion, as assessed by the investigator.
- Secondary Outcome Measures
Name Time Method Stone Free Rate (%) Post-operative Day 30 Stone free is defined as having \<= 4mm residual stones detected by computed tomography (CT), assessed at post-operative Day 30.
Number of Adverse Events Up to post-operative Day 90 Adverse events are defined as any undesirable clinical occurrence in a participant, whether or not it is considered to be device-related.
Number of Procedure Conversions to Conventional Treatment Methods due to study device-related safety event Procedure Visit, Day 0 Number of procedures converted to conventional stone removal procedures (e.g., ureteroscopy or percutaneous nephrolithotomy) due to the occurrence of a study device-related safety event.
Trial Locations
- Locations (2)
Indiana University
🇺🇸Indianapolis, Indiana, United States
UW School of Medicine and Public Health
🇺🇸Madison, Wisconsin, United States