Preclinical evaluation of the versius surgical system, a new robot-assisted surgical device for use in minimal access general and colorectal procedures

Morton, J.; Hardwick, Richard; Tilney, H. S.; Gudgeon, A. M.; Jah, Asif; Stevens, L.; Marecik, Sławomir; Slack, Mark

doi:10.1007/s00464-020-07622-4

Cited by 55 publications

(51 citation statements)

References 16 publications

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“…This study shows promising first-in-human clinical trial data that support previous preclinical study results [18][19][20]. All 30 cases presented in this analysis were completed successfully and provide evidence supporting continued recruitment into the trial and inclusion of major surgical procedures.…”

Section: Conclusion and Future Perspectivessupporting

confidence: 78%

“…The goal of the initial preclinical and Idea stages (Stage 0 and 1) is proof of concept-this was demonstrated through usability studies and procedure-specific assessment in cadavers and porcine models. [15,16,[18][19][20]. These studies provided an opportunity to optimise the operational set up of the robot by confirming optimal BSU positions, port placings and procedural steps.…”

mentioning

confidence: 86%

“…No procedure required conversion to conventional MAS or open surgery, all procedures were completed successfully and there were no intra-operative complications. The procedures were performed according to the procedural steps described in the preclinical studies, therefore there was no need to modify steps during this clinical phase [18,19]. Intra-operative blood loss was estimated as negligible (< 5 mL) for 19/30 (63.3%) procedures or minimal (< 500 mL) for 11/30 (36.7%) procedures; only one case (3.3%; Case 15) required the use of blood transfusion products (required post-operatively and not related to intra-operative blood loss reported).…”

Section: Patient Outcomesmentioning

confidence: 99%

“…Likewise, the feasibility of Versius for transanal and mesorectal excision has also been evaluated [17]. Additional preclinical studies demonstrated that Versius can be used to successfully complete a range of gynaecological, urological, renal and general surgical procedures in both cadavers and live porcine studies [18][19][20].…”

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confidence: 99%

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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

et al. 2020

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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.

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Section: Conclusion and Future Perspectivessupporting

confidence: 78%

mentioning

confidence: 86%

Section: Patient Outcomesmentioning

confidence: 99%

mentioning

confidence: 99%

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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

et al. 2020

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“…Its design is aimed at overcoming some of the shortcomings of robotic-assisted devices and has been optimised based on feedback from a number of surgeons [4]. Versius ® also has an open console design which is intended to improve communication between the operating surgeon and the wider theatre team [5]. We report the first in human series of major colorectal resections performed using Versius ® in a single, previously robot-naïve, centre in the UK.…”

Section: Introductionmentioning

confidence: 99%

Major colorectal resection is feasible using a new robotic surgical platform: the first report of a case series

et al. 2020

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Background The number of abdominal procedures performed via a robotic-assisted approach is increasing as potential advantages of the modality are recognised. We report the first in human case series of major colorectal resection performed using a new system, Versius ® , and assess the feasibility of its use. Methods The initial cases performed using Versius ® at a single centre in the UK were included in the study. Anonymised data were prospectively collected including patient demographics, operative details and postoperative outcomes. Results Twenty-three operations were performed, including left (n = 14) and right (n = 9)-sided colonic resections. Rectal mobilisation was performed in 13. Fifty-seven percent of the patients were male, with a malignant indication for surgery in 70% of cases. Overall mean age was 59.1 ± 15.3 (range 23-89) years. Overall mean body mass index was 28.9 ± 5.2 with a mean of 31.3 ± 4.5 for left-sided resections. The median console operating time was 166 min (range 75-320 min). All malignant cases had negative resection margins and the mean lymph node yield was 18 (SD 9.4). Only one operation (4%) was converted from robotic to open approach. Postoperative length of stay was a median of 5 days (range 3-34 days) and there were no readmissions within 30 days. Conclusions These results compare favourably with the literature on existing robotic systems and also conventional laparoscopic surgery; hence, we believe that this series indicates the Versius ® system is feasible for use in major colorectal resection. These early results from a robot-naïve centre show exciting promise for an expanding robotic market and highlight the need for further evaluation.

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Preclinical evaluation of the Versius surgical system: A next‐generation surgical robot for use in minimal access prostate surgery

et al. 2023

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Objectives: To evaluate the Versius surgical system for robot-assisted prostatectomy in a preclinical cadaveric model using varying system setups and collect surgeon feedback on the performance of the system and instruments, in line with IDEAL-D recommendations.Materials and methods: Procedures were performed in cadaveric specimens by consultant urological surgeons to evaluate system performance in completing the surgical steps required for a prostatectomy. Procedures were conducted using either a 3-arm or 4-arm bedside unit (BSU) setup. Optimal port placements and BSU layouts were determined and surgeon feedback collected. Procedure success was defined as the satisfactory completion of all steps of the procedure, according to the operating surgeon.Results: All four prostatectomies were successfully completed; two were completed with a 3-arm BSU setup and two using a 4-arm BSU setup. Small adjustments were made to the port and BSU positioning, according to surgeon preference, in order to complete the surgical steps. The surgeons noted some instrument difficulties with the Monopolar Curved Scissor tip and the Needle Holders, which were subsequently refined between the first and second sessions of the study, in line with surgeon feedback. Three cystectomies were also successfully completed, demonstrating the capability of the system to perform additional urological procedures. Conclusions:This study provides a preclinical assessment of a next-generation surgical robot for prostatectomies. All procedures were completed successfully, and port and BSU positions were validated, thus supporting the progression of the system to further clinical development according to the IDEAL-D framework.

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Preclinical evaluation of the versius surgical system, a new robot-assisted surgical device for use in minimal access general and colorectal procedures

Cited by 55 publications

References 16 publications

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

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

Major colorectal resection is feasible using a new robotic surgical platform: the first report of a case series

Preclinical evaluation of the Versius surgical system: A next‐generation surgical robot for use in minimal access prostate surgery

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