The LARC Robot Simplifies Renal Access In Percutaneous Nephrolithotomy

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07211555
• Lead Sponsor: AdventHealth

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-16
• Study First Submitted QC: 2025-09-30
• Last Update Submitted: 2025-09-30
• Study First Posted: 2025-10-08
• Last Update Posted: 2025-10-08
• Study Start: 2025-11-01
• Primary Completion: 2025-11-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Stone-Free Rate (SFR)	Within 30 days post-procedure	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).
Procedure Success Rate	During procedure (Day 0)	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.

Secondary Outcome Measures

Name	Time	Method
Estimated Blood Loss (EBL)	During procedure (Day 0)	Volume of blood loss (in mL) recorded during PCNL using the LARC system, measured via standard intraoperative methods.
Operative Time	During procedure (Day 0)	Total time (in minutes) from skin incision to procedure completion. Sub-analysis includes time from renal access start to access success.
Radiation Exposure	During procedure (Day 0)	Total fluoroscopy time and radiation dose (in mGy and seconds) recorded during robotic-assisted access using the LARC system.
Postoperative Complications	Up to 30 days post-procedure	All adverse events will be recorded and graded using the Clavien-Dindo classification system. Includes infection, transfusion, organ injury, and reintervention.
Number of Access Attempts	During procedure (Day 0)	Number of needle punctures required to achieve access to the renal collecting system.

Trial Locations

Locations (1)

Advent Health Medical Group Urology at Celebration; 🇺🇸 Celebration, Florida, United States