Robotic-assisted Urological Minimally Invasive Cancer Surgeries using the MicroHand S Surgical Robot System.

Area of Science:

• Urology
• Surgical Robotics
• Minimally Invasive Surgery

Background:

• The MicroHand S surgical robot system is being evaluated for enhanced capabilities in minimally invasive cancer surgeries.
• Clinical trials are essential for validating new surgical technologies according to frameworks like IDEAL-D.

Purpose of the Study:

• To assess the safety and feasibility of the enhanced MicroHand S surgical robot system.
• To evaluate its performance in complex urological cancer surgeries, specifically radical cystectomy, partial nephrectomy, and radical prostatectomy.
• To align with IDEAL-D Framework Stage 2a requirements for surgical innovation.

Main Methods:

• Procedures were conducted by an experienced urologist using the MicroHand S system.
• The study enrolled patients undergoing radical cystectomy, partial nephrectomy, or radical prostatectomy.
• Primary endpoint was unplanned conversion rate; adverse events (AEs) and serious adverse events (SAEs) were monitored and adjudicated by an independent committee. Patients were followed for 1 year.

Main Results:

• A total of 23 procedures were performed: 12 radical cystectomies, 8 radical prostatectomies, and 3 partial nephrectomies.
• All surgeries were successfully completed using the MicroHand S system without conversion to open or laparoscopic approaches.
• No device- or instrument-related AEs occurred, and all patients experienced Grade I postoperative complications (Clavien-Dindo), with no 24-hour returns to the OR or 1-year tumor recurrence.

Conclusions:

• The MicroHand S system demonstrates safety and feasibility for complex urological minimally invasive cancer surgeries (MICS).
• The system's successful application supports its progression to further clinical trials.
• This evaluation aligns with IDEAL-D Framework Stage 2a, indicating readiness for broader clinical investigation.