The LARC Robot Simplifies Renal Access In Percutaneous Nephrolithotomy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAdventHealth

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)

Treatment groups

45 Participants
are divided into 1 treatment group

Sponsors and collaborators