About this trial
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.
Eligibility criteria
Qualifiers
Kidney stones larger than 2 cm
Staghorn renal calculi
Lower pole stones less than 2 cm
Horseshoe kidney
Disqualifiers
Pregnancy
Active urinary tract infection (UTI) or untreated sepsis
Known bleeding disorders or uncorrectable coagulopathy despite medical management
Use of anticoagulant medications (e.g., warfarin, heparin, or DOACs) that cannot be safely discontinued
Trial design
Treatments tested in this trial
- LARC Robotic System (Micromate™ Version 3.0)