The LARC Robot Simplifies Renal Access In Percutaneous Nephrolithotomy

Part of paid clinical trials in Celebration, Florida.

Sponsor
AdventHealth
Study ID
NCT07211555
Status
Not Yet Recruiting

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Conditions

  • Kidney Calculi
  • Kidney Stones
  • Refractory Kidney Stones
  • Renal Stone Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Nov 1, 2025
Status verified
Jul 2025
Primary completion
Nov 1, 2025
Completion
Jan 1, 2026

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Stone-Free Rate (SFR) [ Time Frame: Within 30 days post-procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Advent Health Medical Group Urology at CelebrationCelebrationFlorida34747
Petronio Martins, MHA
[email protected]
407-303-3603
Bridget Miller, MS, MPH
[email protected]
407-303-3603
Michael McDonald, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Advent Health Medical Group Urology at Celebration· Celebration, FL

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