Safety and Efficacy of the Versius Surgical System in Transoral Robotic Surgery: A Prospective Study
Jason C. Fleming, Katharine Davies, Christopher Loh, Mark Wilkie, Xander Lawson, Saul Truckle, James Constable, Jennifer Gwinnutt, Jennifer Rodrigues, Paul Banks, Zoe Mellor, Terry M. JonesAbstract
Objective
To evaluate the safety and feasibility of the Versius surgical robotic system for transoral robotic surgery in benign and malignant head and neck indications.
Study Design
Open‐label, prospective, single‐arm, phase II clinical trial.
Setting
Liverpool Head and Neck Centre, United Kingdom.
Methods
Between December 2023 and March 2025, 62 patients were enrolled, with 60 undergoing transoral robotic surgery on the Versius system. Eligible adults had either confirmed oropharyngeal or unknown primary squamous cell carcinoma, or benign indications (recurrent tonsillitis or peritonsillar abscess). The primary endpoint was successful procedure completion without conversion, and safety was assessed by 30‐day complication incidence. Secondary endpoints included operative and setup times, blood loss, length of stay, nasogastric tube use, readmissions, reoperations and margin status in malignant resections.
Results
All 60 procedures were completed successfully without conversion. Median setup time was 10 minutes and operative time 46 minutes. Estimated blood loss was <100 mL in 98% of cases, with no transfusions required. Median hospital stay was 1 day, with a 35% same day discharge rate. No patient required nasogastric tube feeding. Eleven postoperative complications occurred (18.3%), none device‐related, and a secondary hemorrhage rate of 6.7%. Among 28 oncological resections, 25 (89.3%) achieved negative margins, including 21 of 22 (95.7%) cases with T1‐T2 disease.
Conclusion
The Versius surgical robotic system demonstrated high procedural success, low morbidity and oncological outcomes comparable to established robotic platforms. It represents a safe and feasible robotic platform for integration into a contemporary head and neck transoral surgery practice.