Minimal access surgery (MAS) is well-established in urological surgery. However, MAS is technically demanding and associated with a prolonged learning curve. Robot-assisted laparoscopy has made progress in overcoming these challenges. The aim of this study was to evaluate the feasibility of a new robot-assisted surgical system (the Versius Surgical System; CMR Surgical, Cambridge, UK) for renal and prostate procedures in a preclinical setting, at the IDEAL-D phase 0. Cadaveric sessions were conducted to evaluate the ability of the system to complete all surgical steps required for a radical nephrectomy, prostatectomy, and pelvic lymph node dissection. A live animal (porcine) model was also used to assess the surgical device in performing radical nephrectomy safely and effectively. Procedures were performed by experienced renal and prostate surgeons, supported by a full operating room team. Surgical access and reach were evaluated by the lead surgeon using a visual analogue scale. The precise surgical steps conducted to make the assessment that the procedures could be completed fully were recorded, as well as instruments used (including manual laparoscopic instruments) and endoscope angle. In total, all 24 procedures were completed successfully in cadavers by eight different lead surgeons. Positioning of the ports and bedside units reflected the lead surgeon's preferred laparoscopic set-up and enabled good surgical access and reach, as quantified by a median visual analogue score of ≥6.5. Radical nephrectomies performed in pigs were all completed successfully, with no device- or non-device-related intraoperative complications recorded. Testing in human cadavers and pig models balances the bias introduced by each model; however, it is impossible to completely replicate the experience and performance of the robot for surgery in live humans. This is the first preclinical assessment of the Versius Surgical System for renal and prostate procedures. The safety and effectiveness of the system have been demonstrated and warrant progressive assessment in a clinical setting utilising the IDEAL-D framework. In this report, we looked at the usability of a new robot-assisted surgical device for renal and prostate surgery by testing the system in cadavers and pigs. We found that a number of different surgeons and operating team personnel were able to use the system to successfully complete the procedures under evaluation. We conclude that the system is ready to be tested in live human studies.

Objectives Versius is a teleoperated surgical robotic system intended for use in minimal access surgery. This study aimed to validate the safety and effectiveness of the Versius user interface in the hands of trained users and identify and address the causes of any user errors. Design Surgical teams completed a commercially representative training program over 3.5 days. After training was completed, the usability-related aspects of the system were assessed. Setting A simulated operating room using a cadaveric model. Participants Surgical teams consisting of a lead surgeon, assistant surgeon, scrub nurse and circulating nurse. Main outcome measures Usability-related aspects of the system were assessed through the completion of critical and non-critical tasks. A critical task was defined according to the Food and Drug Administration’s definition, as a user task which, if performed incorrectly or not performed at all, would or could cause serious harm to the patient or user, where harm is defined to include compromised medical care. Results In total, 17 surgical teams participated in the study and all were experienced in laparoscopic surgery. The number of robotic surgeries performed by the participants per month ranged from 0 to 100. Surgical specialties were similarly represented from obstetrics and gynecology, colorectal, urology and upper gastrointestinal. No critical task failures were observed. Of all the tasks completed, 98% were recorded as a pass or a pass with difficulty. Conclusions These results demonstrate that in a simulated clinical setting, Versius can be safely used by both laparoscopically and robotically trained healthcare professionals. These results support the progression to assessment of Versius in preclinical studies.

Objective: To evaluate the utility of a new robot-assisted surgical system (the Versius Surgical System, CMR Surgical, Cambridge, UK) for use in minimal access general and colorectal surgery, in a preclinical setting. Summary background data: Robot-assisted laparoscopy has been developed to overcome some of the important limitations of conventional laparoscopy. The new system is designed to assist surgeons in performing minimal access surgery and overcome some of the challenges associated with currently available surgical robots. Methods: Cadaveric sessions were conducted to evaluate the ability of the system to provide adequate surgical access and reach required to complete a range of general and colorectal procedures. Port and bedside unit positions were recorded, and surgical access and reach were evaluated by the lead surgeon using a visual analogue scale. A live animal (porcine) model was used to assess the surgical device’s safety in performing cholecystectomy or small bowel enterotomy. Results: Nine types of procedure were performed in cadavers by nine lead surgeons; 35/38 procedures were completed successfully. The positioning of ports and bedside units reflected the lead surgeons’ preferred laparoscopic set-up and enabled good surgical access and reach. Cholecystectomy (n = 6) and small bowel enterotomy (n = 5) procedures performed in pigs were all completed successfully by two surgeons. There were no device-related intra-operative complications. Conclusions: This preclinical study of a new robot-assisted surgical system for minimal access general and colorectal surgery demonstrated the safety and effectiveness of the system in cadaver and porcine models. Further studies are required to assess its clinical utility.

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.

Objective: The aim of this study was to demonstrate the ability of the Versius Surgical System to successfully and safely complete cholecystectomy. Background: The system has been developed in-line with surgeon feedback to overcome limitations of conventional laparoscopy to enhance surgeon experience and patient outcomes. Here we present results from the cholecystectomy cohort from a completed early clinical trial, which was designed to broadly align with Stage 2b of the Idea, Development, Exploration, Assessment, Long-term follow-up framework for surgical innovation. Methods: Procedures were performed between March 2019 and September 2020 by surgical teams consisting of a lead surgeon and operating room (OR) assistants. Male or female patients aged 18 years and over and requiring cholecystectomy were enrolled. The primary endpoint was the rate of unplanned conversion from robot-assisted surgery to conventional laparoscopic or open surgery. Adverse events (AEs) and serious AEs were adjudicated by video review of the surgery and patient study reports by an independent Clinical Expert Committee. Results: Overall, 134/143 (93.7%) cholecystectomies were successfully completed using the device. Of the 9 (6.3%) conversions to another surgical modality, 7 were deemed to be related to the device. A total of 6 serious AEs and 3 AEs occurred in 8 patients (5.6%), resulting in 4 (2.8%) readmissions to hospital within 30 days of surgery and 1 death. Conclusions: This study demonstrates cholecystectomy performed using the device is as safe and effective as conventional laparoscopy and supports the implementation of the device on a wider scale, pending instrument modifications, in alignment with Idea, Development, Exploration, Assessment, Long-term follow-up Stage 3 (Assessment).

Introduction: This study aimed to demonstrate the safe and effective use of the Versius surgical system (CMR Surgical, Cambridge, UK) in robot‐assisted total laparoscopic hysterectomy. This surgical robot was developed iteratively with input from surgeons to improve surgical outcomes and end‐user experience. We report data from the gynecology cohort of an early clinical trial designed in broad alignment with IDEAL‐D (Idea, Development, Exploration, Assessment, Long‐term follow‐up – Devices) stage 2b (Exploration).Material and methods: The study is registered in the Indian clinical trials register (CTRI/2019/02/017872). Adult women requiring total hysterectomy who provided informed consent and met the eligibility criteria underwent procedures at one of three hospitals in India. Five surgeons performed robot‐assisted total laparoscopic hysterectomies using the device from March 2019 to September 2020. The primary endpoint was rate of unplanned conversion to conventional laparoscopic or open surgery. Adverse events were adjudicated by an independent clinical events committee using endoscope video recordings and clinical notes.Results: In total, 144 women underwent surgery (median age: 44 years [range: 28–78]; median body mass index 25.8 kg/m² [range: 14.3–47.8]). The rate of unplanned conversion to conventional laparoscopy was 2/144 (1.4%); neither conversion was device related. No surgery was converted to open. In total, 13 adverse events occurred among seven (4.9%) patients, comprising seven serious adverse events and six adverse events. One serious adverse event was deemed device‐related. Two patients were readmitted to hospital within 30 days; both made a full recovery. No patients died within 90 days of surgery.Conclusions: The device provides a safe and effective option for total laparoscopic hysterectomy; these findings support its continued implementation in larger patient cohorts and expansion in other major minimal access indications.