The LARC Robot Simplifies Renal Access In Percutaneous Nephrolithotomy

AdventHealth

Status: Not yet enrolling

Conditions: Renal Stone Disease; Kidney Stones; Kidney Calculi; Refractory Kidney Stones

Treatments: Device: LARC Robotic System (Micromate™ Version 3.0)

Study type: Interventional

Funder types: Other

Identifiers

NCT07211555

2196760

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Kidney stones larger than 2 cm
• Staghorn renal calculi
• Lower pole stones less than 2 cm
• Anatomical abnormalities that reduce the likelihood of spontaneous stone fragment passage, such as:
• Horseshoe kidney
• Calyceal diverticulum
• Ectopic or dystopic kidney
• Stones that are refractory to prior treatment (e.g., ESWL or ureteroscopy)
• Suspected malignant tumors or masses located in the planned renal access tract

Exclusion criteria

• 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
• Allergy to contrast media that cannot be pre-medicated or managed
• Severe cardiopulmonary comorbidities that contraindicate anesthesia or PCNL
• Inability to provide informed consent
• Participation in another investigational study that may interfere with study outcomes

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Assisted PCNL Using LARC System

Experimental group

Description:

This arm includes participants who will undergo percutaneous nephrolithotomy (PCNL) with renal access guided by the investigational LARC robotic system (Version 3.0). The procedure uses fluoroscopy-based navigation to assist the urologist in targeting the renal collecting system.

Treatment:

Device: LARC Robotic System (Micromate™ Version 3.0)