The LARC Robot Simplifies Renal Access In Percutaneous Nephrolithotomy

September 30, 2025 updated by: AdventHealth

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Assisted PCNL Using LARC System
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Within 30 days post-procedure
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.
During procedure (Day 0)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During procedure (Day 0)
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.
During procedure (Day 0)
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.
During procedure (Day 0)
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.
Up to 30 days post-procedure
Number of Access Attempts
Time Frame: During procedure (Day 0)
Number of needle punctures required to achieve access to the renal collecting system.
During procedure (Day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2025

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

July 16, 2025

First Submitted That Met QC Criteria

September 30, 2025

First Posted (Estimated)

October 8, 2025

Study Record Updates

Last Update Posted (Estimated)

October 8, 2025

Last Update Submitted That Met QC Criteria

September 30, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2196760

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We will not be sharing information from this study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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