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The LARC Robot Simplifies Renal Access In Percutaneous Nephrolithotomy (PCNL)
This study is being done to evaluate a new robotic system that helps urologists more precisely reach the kidney during surgery to remove large kidney stones. The procedure, called percutaneous nephrolithotomy (PCNL), is typically used for people who have large or difficult-to-remove kidney stones. Traditionally, many urologists rely on radiologists to place a tube into the kidney before surgery. This can cause delays, require multiple procedures, and increase costs. The robotic system being studied - called LARC - is designed to help the urologist safely and accurately guide a needle directly into the kidney during the surgery, without needing a separate procedure beforehand. The robot uses live X-ray images to help align the instruments. Although parts of the robot have been approved by the U.S. FDA, the version used in this study is still investigational and not yet approved for this specific purpose. The study will take place at AdventHealth Celebration and include up to 45 adult patients who are scheduled for PCNL surgery. Participants will be followed for up to 1 month after surgery, and doctors will look at outcomes such as the success of the procedure, the number of kidney stones removed, complications, time in surgery, and radiation exposure. This research may help make kidney stone surgery safer, faster, and more effective in the future.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Advent Health Medical Group Urology at Celebration
Celebration, Florida, United States
Start Date
November 1, 2025
Primary Completion Date
November 1, 2025
Completion Date
January 1, 2026
Last Updated
October 8, 2025
45
ESTIMATED participants
LARC Robotic System (Micromate™ Version 3.0)
DEVICE
Petronio Senior Clinical Research Operations Manager, MHA
CONTACT
407-303-3603Petronio.martins@adventhealth.comBridget Clinical Research Operations Manager, MS, MPH
CONTACT
407-303-3603Bridget.Miller@adventhealth.comLead Sponsor
AdventHealth
NCT07159503
NCT06938113
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06819111