Safety and Usability of a Novel, Robotic Assistance System for Echocardiographic Examination

Background: Transthoracic echocardiography (TTE) is essential for modern cardiac diagnostics, yet it is difficult to access in remote areas. Remotely operated robotic-assisted ultrasound may enable access to services in rural and remote locations, while also improving ergonomics for the sonographer. This study evaluated the safety, usability and patient satisfaction of a novel robotic ultrasound assistance tool (RUAT). Methods: This open-label, single-site, single-arm clinical trial enrolled adult participants who had recently completed a standard manual echocardiogram. A trained sonographer performed a robot-assisted TTE from a dedicated workstation in the same room as the patient. Endpoints included safety measured by adverse events, technical and clinical usability, and patient satisfaction using surveys about the participants’ experience. Results: The trial cohort (n=30; mean age 62.9 ± 17.5 years; 70% men) all successfully completed the robot-assisted TTE and the patient satisfaction survey. There were no adverse events or adverse device effects. The functional verification checklist supporting technical usability demonstrated an average usability rate of 96.9% (95% CI [98.9–100.0]), with a 100% rate across 10 of 12 metrics. The sonographer’s review of the acquired robotic images measured the clinical usability and 29 of 30 examinations met acceptable diagnostic standards (96.7%; 95% CI [88.1–100.0]). The mean participant satisfaction score was 8.3 out of 10, with 96.7% scoring ≥6. Conclusion: The RUAT demonstrated high technical and clinical usability, as well as high acceptance by participants. These findings indicate that robot-assisted TTE is a viable strategy to enhance remote access to TTE services.