NCT07211555

The LARC Robot Simplifies Renal Access In Percutaneous Nephrolithotomy

The LARC Robot Simplifies Renal Access In Percutaneous Nephrolithotomy (PCNL)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: AdventHealth · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Renal Stone Disease
• Kidney Calculi
• Refractory Kidney Stones
• Kidney Stones

Interventions

Type	Name	Description
DEVICE	LARC Robotic System (Micromate™ Version 3.0)	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.

Timeline

• Start date: 2025-11-01
• Primary completion: 2025-11-01
• Completion: 2026-01-01
• First posted: 2025-10-08
• Last updated: 2025-10-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study