ALERT!
This site is not optimized for Internet Explorer 8 (or older).
Please upgrade to a newer version of Internet Explorer or use an alternate browser such as Chrome or Firefox.
Implementation of the Versius Robotic Surgical System for Thoracic Surgery: First Clinical Evaluation of Feasibility and Performance
Submitted by
Source
The aim of this study was to demonstrate the ability of the Versius Surgical System to successfully and safely complete a range of thoracic procedures aligned with phase 2a of the (Development) of the Idea, Development, Exploration, Assessment and Long-term follow-up (IDEAL) framework for surgical innovation.
This prospective study included the first 30 consecutive patients who underwent robotic surgery with Versius by two surgeons without prior robotic experience between 1 April 2023 and 30 December2023 (25 lung resections [i.e., wedge, segmentectomy, lobectomy] and 5 thymectomies). There were no specific predetermined selection criteria for each case. The primary outcome was safe completion of the procedure without unplanned conversion. Secondary outcomes included intraoperative and postoperative complications, intraoperative device-related outcomes, and pathology results.
Twenty-eight cases (93.3 percent) were completed without conversion. Both conversions were to thoracoscopy, one due to a console alarm and the other due to a pulmonary artery bleeding. In lung resections, the median console time was 103 (90–129) minutes. Five patients (20 percent) experienced postoperative complications, the most frequent was persistent air leak (16 percent). The median length –of stay was 3 (2–4) days. Neither readmissions nor mortality was observed. In thymectomies, no intraoperative or postoperative complications, readmissions, reinterventions or mortality were observed. The median console time was 77 (75–89) minutes and the median length of stay was 1 (1–1) day.
This phase 2a IDEAL-D study confirms lung resections and thymectomies are feasible with the use of Versius system, laying the foundation for larger phase 2b and 3 clinical studies within the IDEAL-D framework.