Robotic guidance for ultrasound-guided percutaneous procedures: a prospective multispecialty feasibility study

To evaluate the safety, feasibility, and technical performance of a handheld robotic guidance system for ultrasound-guided percutaneous procedures across multiple procedural domains.

A prospective, single-center, open-label feasibility study evaluated the Focalist™ handheld robotic guidance system (Mendaera Inc., USA) across multiple ultrasound-guided percutaneous procedures was performed between December 3 and December 11, 2025. Patients undergoing clinically indicated organ access, vascular access, or pain management injection procedures for urologic conditions were prospectively enrolled. Primary endpoints were safety and technical success. Secondary endpoints included procedural performance metrics and operator-reported user experience.

A total of 61 ultrasound-guided percutaneous procedures were performed in 46 patients by 11 operators. Procedure categories included 20 organ access procedures, 31 pain management injections, and 10 vascular access procedures, including 15 specific procedures that had never previously been performed using the system. Technical success was achieved in 60 of 61 procedures (98.4%), with no device-related adverse events. First-attempt success occurred in 45 procedures (74%), with a mean of 1.4 needle attempts per procedure. Mean robotic procedure time (sterile scan start to needle at target) was 5.6 min. Operator survey responses indicated agreement that the system was easy to use (mean 3.7/5) and enhanced confidence during procedures (mean 3.7/5).

In this prospective feasibility study, a novel handheld robotic ultrasound guidance system was used successfully across a diverse range of ultrasound-guided percutaneous procedures. High technical success and absence of device-related adverse events support consideration of its inclusion in standard of care workflows.

CTRI/2025/11/098124.

NCT07358351.