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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
The LARC Robotic System (Version 3.0) is an investigational configuration of the Micromate™ robotic platform by iSYS Medizintechnik GmbH (Austria). It uses fluoroscopy-based surgical navigation to assist urologists in obtaining precise renal access during percutaneous nephrolithotomy (PCNL). This version is not FDA-cleared and is being evaluated for feasibility, safety, and potential clinical benefit.
Advent Health Medical Group Urology at Celebration
Celebration, Florida, United States
Stone-Free Rate (SFR)
Proportion of participants with no residual kidney stones larger than 4 mm, as determined by imaging (non-contrast CT, KUB X-ray, or renal ultrasound).
Time frame: Within 30 days post-procedure
Procedure Success Rate
Proportion of procedures in which the urologist was able to successfully obtain renal access and complete the PCNL using the LARC robotic system, without converting to manual or radiologist-assisted access.
Time frame: During procedure (Day 0)
Estimated Blood Loss (EBL)
Volume of blood loss (in mL) recorded during PCNL using the LARC system, measured via standard intraoperative methods.
Time frame: During procedure (Day 0)
Operative Time
Total time (in minutes) from skin incision to procedure completion. Sub-analysis includes time from renal access start to access success.
Time frame: During procedure (Day 0)
Radiation Exposure
Total fluoroscopy time and radiation dose (in mGy and seconds) recorded during robotic-assisted access using the LARC system.
Time frame: During procedure (Day 0)
Postoperative Complications
All adverse events will be recorded and graded using the Clavien-Dindo classification system. Includes infection, transfusion, organ injury, and reintervention.
Time frame: Up to 30 days post-procedure
Number of Access Attempts
Number of needle punctures required to achieve access to the renal collecting system.
Time frame: During procedure (Day 0)
Petronio Senior Clinical Research Operations Manager, MHA
CONTACT
Bridget Clinical Research Operations Manager, MS, MPH
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