LARC Robot for Kidney Stones

Overseen By Bridget Clinical Research Operations Manager, MS, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: AdventHealth

Must not be taking: Anticoagulants

Disqualifiers: Pregnancy, UTI, Bleeding disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new robotic system, the LARC Robotic System, to assist with surgery for large or hard-to-remove kidney stones. The robot guides a needle into the kidney more precisely during percutaneous nephrolithotomy (PCNL), potentially making the surgery safer and quicker. The trial includes individuals with large kidney stones, stones in difficult locations, or stones unresponsive to other treatments. Researchers will monitor participants for a month after surgery to evaluate the robot's effectiveness. This research could enhance future kidney stone surgeries. As an unphased trial, it offers participants the chance to contribute to pioneering research that may revolutionize kidney stone surgery.

Will I have to stop taking my current medications?

The trial requires that you stop taking anticoagulant medications (blood thinners) like warfarin, heparin, or DOACs if they cannot be safely discontinued. For other medications, the protocol does not specify, so it's best to discuss with the study team.

What prior data suggests that the LARC robotic system is safe for kidney stone surgery?

Research has shown that the LARC robotic system could make kidney stone removal surgery safer and more precise. In earlier studies, the LARC system enabled surgeons to reach the kidney directly and accurately during surgery. This reduces the need for additional procedures and may help avoid delays and lower costs.

Some parts of the LARC robot have already received FDA approval for other uses. However, the version being tested for kidney stone surgery remains experimental. Early findings suggest that patients might undergo safer surgery, spend less time in the operating room, and experience fewer complications afterward. There is also potential for reduced radiation exposure, which is always beneficial.

Overall, while this new robotic system is still under study, the evidence so far suggests it might be safe and helpful for patients needing kidney stone surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the LARC Robotic System for kidney stones because it introduces a new level of precision in the procedure known as percutaneous nephrolithotomy (PCNL). Unlike traditional methods that rely heavily on manual navigation, this system uses advanced fluoroscopy-based navigation to guide the urologist directly to the kidney stones. This technology could potentially reduce complications and improve outcomes by providing more accurate targeting of the renal collecting system. By enhancing the precision and safety of the procedure, the LARC system could represent a significant advancement over current standard-of-care options for kidney stone removal.

What evidence suggests that the LARC robotic system is effective for kidney stone surgery?

Research has shown that the LARC robotic system, which participants in this trial will use, could enhance the precision and efficiency of kidney stone surgeries. Studies indicate that using a robot during kidney stone removal surgery, known as percutaneous nephrolithotomy (PCNL), helps surgeons reach the kidney more accurately. This precision could lead to fewer complications and a better chance of removing all stones in one procedure. The LARC robot uses live X-ray images to guide tools directly into the kidney, potentially reducing the need for multiple surgeries and shortening operation time. Although still under study for this specific use, early results suggest it could make the surgery safer and quicker. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

Adult patients scheduled for PCNL surgery to remove large or difficult kidney stones can participate. The trial is testing a new robotic system, LARC, which aims to simplify the surgical process.

Inclusion Criteria

My kidney stone is smaller than 2 cm.

I have kidney stones larger than 2 cm.

I have large kidney stones that fill the kidney.

Exclusion Criteria

Allergy to contrast media that cannot be pre-medicated or managed

Inability to provide informed consent

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo percutaneous nephrolithotomy (PCNL) with renal access guided by the investigational LARC robotic system

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the PCNL procedure

4 weeks

1-2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• LARC Robotic System

Trial Overview The LARC Robotic System (Micromate™ Version 3.0) is being evaluated for its ability to guide urologists in accurately reaching the kidney during PCNL surgery using live X-ray images.

How Is the Trial Designed?

Group I: Assisted PCNL Using LARC System Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

AdventHealth

Lead Sponsor

Trials

118

Recruited

31,800+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07211555

NCT07211555 | The LARC Robot Simplifies Renal Access ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12230907/

New Technology in Percutaneous Nephrolithotomy The introduction of robotics has revolutionized PCNL by improving surgical outcomes and enhancing surgeons' capabilities. Notably, several studies have explored ...

3. ctv.veeva.com ctv.veeva.com/study/the-larc-robot-simplifies-renal-access-in-percutaneous-nephrolithotomy

The LARC Robot Simplifies Renal Access In Percutaneous ... This study is being done to evaluate a new robotic system that helps urologists more precisely reach the kidney during surgery to remove ...

4. surgicalroboticstechnology.com surgicalroboticstechnology.com/company/larc-robotics/

robotic solutions for percutaneous renal access LARC Robotics is developing robotic solutions aiming to render every patient stone-free in a single percutaneous nephrolithotomy (PCNL) procedure.

5. app.trialscreen.org app.trialscreen.org/trials/larc-robot-simplifies-renal-access-percutaneous-nephrolithotomy-trial-nct07211555

The LARC Robot Simplifies Renal Access In Percutaneous ... Participants may experience a safer, more precise surgery with potentially shorter surgery time and no need for a separate pre-surgery procedure. This could ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40271897/

New Technology in Percutaneous Nephrolithotomy This review highlights significant innovations in percutaneous nephrolithotomy including integrated navigation systems, robotics, artificial intelligence, and ...