Kidney Calculi, Kidney Stones, Refractory Kidney Stones, Renal Stone Disease
Conditions
Keywords
Robotic Surgery, Minimally Invasive Surgery
Brief summary
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.
Interventions
DEVICELARC 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.
Sponsors
AdventHealth
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stone-Free Rate (SFR) | 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). |
| Procedure Success Rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Radiation Exposure | During procedure (Day 0) | Total fluoroscopy time and radiation dose (in mGy and seconds) recorded during robotic-assisted access using the LARC system. |
| Estimated Blood Loss (EBL) | During procedure (Day 0) | Volume of blood loss (in mL) recorded during PCNL using the LARC system, measured via standard intraoperative methods. |
| Number of Access Attempts | During procedure (Day 0) | Number of needle punctures required to achieve access to the renal collecting system. |
| Postoperative Complications | 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. |
| Operative Time | 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. |
Countries
United States
Contacts
Primary ContactPetronio Senior Clinical Research Operations Manager, MHA
Backup ContactBridget Clinical Research Operations Manager, MS, MPH
Outcome results
None listed