The LARC Robot Simplifies Renal Access In Percutaneous Nephrolithotomy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAdventHealth
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Kidney stones larger than 2 cm
Staghorn renal calculi
Lower pole stones less than 2 cm
Horseshoe kidney
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
LARC Robotic System (Micromate™ Version 3.0)
DeviceThe 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.
Treatment groups
45 Participants
are divided into 1 treatment groupGroup A: Assisted PCNL Using LARC SystemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Stone-Free Rate (SFR)
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).
Time frame
Within 30 days post-procedure2
Procedure Success Rate
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.
Time frame
During procedure (Day 0)Secondary outcomes
1
Estimated Blood Loss (EBL)
Volume of blood loss (in mL) recorded during PCNL using the LARC system, measured via standard intraoperative methods.
Time frame
During procedure (Day 0)2
Operative Time
Total time (in minutes) from skin incision to procedure completion. Sub-analysis includes time from renal access start to access success.
Time frame
During procedure (Day 0)3
Radiation Exposure
Total fluoroscopy time and radiation dose (in mGy and seconds) recorded during robotic-assisted access using the LARC system.
Time frame
During procedure (Day 0)4
Postoperative Complications
All adverse events will be recorded and graded using the Clavien-Dindo classification system. Includes infection, transfusion, organ injury, and reintervention.
Time frame
Up to 30 days post-procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: