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NCT Number: NCT07211555

The LARC Robot Simplifies Renal Access In Percutaneous Nephrolithotomy

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.

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Key information

Conditions

Renal Stone Disease Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Kidney Stones Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Refractory Kidney Stones Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Stone-Free Rate (SFR)

    Time frame: 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).

  2. Procedure Success Rate

    Time frame: 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 outcomes

  1. Estimated Blood Loss (EBL)

    Time frame: During procedure (Day 0)

    Volume of blood loss (in mL) recorded during PCNL using the LARC system, measured via standard intraoperative methods.

  2. Operative Time

    Time frame: 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.

  3. Radiation Exposure

    Time frame: During procedure (Day 0)

    Total fluoroscopy time and radiation dose (in mGy and seconds) recorded during robotic-assisted access using the LARC system.

  4. Postoperative Complications

    Time frame: 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.

  5. Number of Access Attempts

    Time frame: During procedure (Day 0)

    Number of needle punctures required to achieve access to the renal collecting system.

Study contacts

Contact information is provided by the study sponsor or research team.

Bridget Clinical Research Operations Manager, MS, MPH

CONTACT

[email protected]

407-303-3603

Petronio Senior Clinical Research Operations Manager, MHA

CONTACT

[email protected]

407-303-3603

Sponsors and collaborators

Lead sponsor

AdventHealth

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Oct 8, 2025
Registry last updated
Oct 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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