Interim safety analysis of the first-in-human clinical trial of the Versius surgical system, a new robot-assisted device for use in minimal access surgery

Abstract

Objective The aim of this study was to provide an interim safety analysis of the first 30 surgical procedures performed using the Versius Surgical System. Background Robot-assisted laparoscopy has been developed to overcome some of the important limitations of conventional laparoscopy. The new system is currently undergoing a first-in-human prospective clinical trial to confirm the safety and effectiveness of the device when performing minimal access surgery (MAS). Methods Procedures were performed using Versius by a lead surgeon supported by an operating room (OR) team. Male or female patients aged between 18 and 65 years old and requiring elective minor or intermediate gynaecological or general surgical procedures were enrolled. The primary endpoint was the rate of unplanned conversion of procedures to other MAS or open surgery. Results The procedures included nine cholecystectomies, six robot-assisted total laparoscopic hysterectomies, four appendectomies, five diagnostic laparoscopy cases, two oophorectomies, two fallopian tube recanalisation procedures, an ovarian cystectomy and a salpingo-oophorectomy procedure. All procedures were completed successfully without the need for conversion to MAS or open surgery. No patient returned to the OR within 24 h of surgery and readmittance rate at 30 and 90 days post-surgery was 1/30 (3.3%) and 2/30 (6.7%), respectively. Conclusions This first-in-human interim safety analysis demonstrates that the Versius Surgical System is safe and can be used to successfully perform minor or intermediate gynaecological and general surgery procedures. The cases presented here provide evidence that the Versius clinical trial can continue to extend recruitment and begin to include major procedures, in alignment with the IDEAL-D Framework Stage 2b: Exploration.

Assessment of the Versius Robotic Surgical System in Minimal Access Surgery: A Systematic Review

“…The investigations had been conducted in Germany (n = 1), the United States (USA) (n = 3), the United Kingdom (UK) (n = 8), the USA and the UK (n = 1), and India (n = 4). The investigations had been performed on cardboard boxes (n = 1) (40); human cadavers (n = 5) [13,22,23,27,28]; human cadavers and live animals (n = 3) [24][25][26]; and live humans (n = 7) [20,[29][30][31][32][33][34][35]. Results were divided into the following two categories: (a) usability, safety, and effectiveness of the Versius system (9 studies); and (b) clinical safety and effectiveness of the Versius system for use in MAS (8 studies).…”

“…A year after the Versius surgical robotic system was introduced in the market, many surgeons started to use it in visceral, gynecological, and urological surgery despite a limited body of scientific data concerning its feasibility and safety [21]. In conjunction with the primary use of the system in MAS, scientists performed preliminary studies in human cadavers and live animals as well as preclinical investigations to evaluate the operational safety and feasibility of the system [13,20,[22][23][24][25][26][27][28][29][30][31][32][33][34][35]. Given the novelty of the device and the small number of existing studies, scientists and surgeons have been unable to draw final conclusions about the safety and effectiveness of the robot.…”

A Scoping Review of Emerging and Established Surgical Robotic Platforms With Applications in Urologic Surgery

“…Although not performed with the final product, pre-clinical trials using Versius were completed, with a total of 24 surgeries performed (radical nephrectomy, radical prostatectomy, and pelvic lymph node dissection), with no device or non-device intraoperative complications [38]. Human clinical trials using the platform have been limited to gynecologic and general surgery procedures [39].…”

Advances and Trends in Pediatric Minimally Invasive Surgery

“…CMR Surgical (Cambridge, UK) developed the Versius robotic system, which has already been clinically applied and evaluated in general surgical, urological and gynecological procedures [ 125 , 126 , 127 , 128 , 129 , 130 ]. With its 5 mm diameter fully wristed instruments its application in pediatric surgery appears promising.…”