The LARC Robot Simplifies Renal Access In Percutaneous Nephrolithotomy

N/ANot Yet RecruitingNCT07211555

AdventHealth45 enrolled

Overview

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

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Renal Stone Disease

Interventions

LARC Robotic System (Micromate™ Version 3.0)DEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.