Using end-user feedback to optimize the design of the Versius Surgical System, a new robot-assisted device for use in minimal access surgery

BackgroundRobot-assisted minimal access surgery (MAS) reduces blood loss, recovery time, intraoperative and postoperative complications and pain. However, uptake of robotic MAS remains low, suggesting there are barriers to its use. To overcome these barriers, a new surgical robot system, Versius, was developed based on the needs and feedback of surgeons and surgical teams.MethodsThe surgical robot prototype was designed based on observations in the operating room (OR) and previous interviews with surgeons. Formative studies with surgeons and surgical teams were used to refine the prototype design, resulting in modifications to all components, including the arms, instruments, handgrips and surgeon console. Proof-of-concept cadaver studies were used to further optimize its design by assessing its usability during surgical procedures.ResultsFeedback led to the development of a novel, mobile design with independent arm carts and surgical console, linked by supported serial or parallel connections, providing maximum flexibility in the OR. Instrument tips were developed based on surgeons’ preferred designs and wristed at the tip providing seven degrees of freedom within the patient. Multiple handgrip designs were assessed by surgeons; of these, a ‘game controller’ design was rated most popular and usable. An open surgical console design allowing multiple working positions was rated highest by surgeons and the surgical teams.ConclusionsThis surgical robot system has been developed using feedback from end users throughout the design process and aims to minimize barriers to robotic MAS uptake. Additionally, these studies demonstrate system success in the surgical procedures it was designed for. The studies reported here, and further studies of the Versius Surgical System, are intended to align with IDEAL (Idea, Development, Exploration, Assessment, Long-term study) Framework guidance.

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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

Surgical Endoscopy ◽

10.1007/s00464-020-08014-4 ◽

2020 ◽

Author(s):

Dhananjay Kelkar ◽

Mahindra A. Borse ◽

Girish P. Godbole ◽

Utkrant Kurlekar ◽

Mark Slack

Keyword(s):

Clinical Trial ◽

Surgical Procedures ◽

Open Surgery ◽

Safety Analysis ◽

Minimal Access Surgery ◽

Minimal Access ◽

Robot Assisted ◽

Post Surgery ◽

Access Surgery ◽

Surgical System

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.

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Preclinical evaluation of a new robot-assisted surgical system for use in gynecology minimal access surgery

Gynecological Surgery ◽

10.1186/s10397-020-01069-0 ◽

2020 ◽

Vol 17 (1) ◽

Author(s):

Marcus Carey ◽

Anish Bali ◽

Ivilina Pandeva ◽

Ashish Pradhan ◽

Mark Slack

Keyword(s):

Minimal Access Surgery ◽

Minimal Access ◽

Robot Assisted ◽

Preclinical Evaluation ◽

Access Surgery ◽

Surgical System

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New Tools for a New Job-Single Port Laparoscopic Surgery Equipment

Medical Equipment Insights ◽

10.4137/mei.s3144 ◽

2009 ◽

Vol 2 ◽

pp. MEI.S3144 ◽

Cited By ~ 1

Author(s):

Euan R. MacDonald ◽

Ewan Brownlee ◽

Irfan Ahmed

Keyword(s):

Laparoscopic Surgery ◽

Surgical Procedures ◽

Single Port ◽

Minimal Access Surgery ◽

Minimal Access ◽

Scarless Surgery ◽

Single Port Surgery ◽

Instrument Technology ◽

Access Surgery

Single port transumbilical laparoscopic surgery (LESS, SILS, ENOTES) is a technique which has recently emerged with a view to improving the cosmesis following minimal access surgery, aiming to achieve ‘scarless’ surgery. This rapidly progressing technique is facilitated by developments in port and instrument technology, allowing surgeons to perform a wider range of surgical procedures with increasing ease. This paper aims to summarise the equipment available at present for single port surgery.

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The Centre for Minimal Access Surgery—teaching for tomorrow

Journal of Telemedicine and Telecare ◽

10.1258/1357633001935798 ◽

2000 ◽

Vol 6 (2_suppl) ◽

pp. 14-15 ◽

Cited By ~ 1

Author(s):

Lianne Durst

Keyword(s):

Skill Acquisition ◽

Surgical Procedures ◽

Surgical Techniques ◽

The Body ◽

Minimal Access Surgery ◽

Research Centre ◽

Minimal Access ◽

Technological Education ◽

Human Form ◽

Access Surgery

The Centre for Minimal Access Surgery (CMAS) was established as a state-of-the-art multidisciplinary technological education and research centre for minimal access surgical techniques. Up-to-date training models were obtained to facilitate skill acquisition. Among these were the Minimal Access Therapy trainer and the Body Form Simulator, which provide simulations of the human form on which students can practise operative procedures. The CMAS also acquired the MIST Virtual Reality system, a computer program that facilitates the acquisition of laparoscopy skills. Finally, the CMAS compiled a multimedia library of resources. While many skills can be gained in these synthetic and didactic environments, they cannot provide all the preparation necessary to practise competently. To facilitate the realtime observation of surgical procedures and the telementoring process, the CMAS has commissioned the development of an integrated videoconferencing system that permits the high-quality, rapid transfer of multi-feed video and audio data of surgical procedures from an operating room to the classroom.

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Usability assessment of Versius, a new robot-assisted surgical device for use in minimal access surgery

BMJ Surgery, Interventions, & Health Technologies ◽

10.1136/bmjsit-2019-000028 ◽

2020 ◽

Vol 2 (1) ◽

pp. e000028 ◽

Cited By ~ 1

Author(s):

Fiona Haig ◽

Ana Cristina Barbosa Medeiros ◽

Karen Chitty ◽

Mark Slack

Keyword(s):

Minimal Access Surgery ◽

Minimal Access ◽

Usability Assessment ◽

Surgical Device ◽

Critical Task ◽

Surgical Teams ◽

Robotic Surgeries ◽

Access Surgery ◽

Upper Gastrointestinal ◽

Cadaveric Model

ObjectivesVersius 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.DesignSurgical teams completed a commercially representative training program over 3.5 days. After training was completed, the usability-related aspects of the system were assessed.SettingA simulated operating room using a cadaveric model.ParticipantsSurgical teams consisting of a lead surgeon, assistant surgeon, scrub nurse and circulating nurse.Main outcome measuresUsability-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.ResultsIn 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.ConclusionsThese 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.

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Assessment of the training program for Versius, a new innovative robotic system for use in minimal access surgery

BMJ Surgery, Interventions, & Health Technologies ◽

10.1136/bmjsit-2020-000057 ◽

2021 ◽

Vol 3 (1) ◽

pp. e000057

Author(s):

Jessica Butterworth ◽

Margaux Sadry ◽

Danielle Julian ◽

Fiona Haig

Keyword(s):

Training Program ◽

Depth Perception ◽

Program Completion ◽

Minimal Access Surgery ◽

Minimal Access ◽

Robotic Control ◽

Extensive Experience ◽

Robotic Skills ◽

Surgical Teams ◽

Access Surgery

ObjectivesThe Versius surgical system has been developed for use in robot-assisted minimal access surgery (MAS). This study aimed to evaluate the effectiveness of the Versius training program.DesignA 3.5-day program following 10 hours of online didactic training. Participants were assessed during the technical training using the Global Evaluative Assessment of Robotic Skills (GEARS).SettingDry box exercises were conducted in classrooms, and wet lab sessions simulated an operating room environment using cadaveric specimens.ParticipantsSeventeen surgical teams participated; surgeons represented general, colorectal, obstetrics/gynecology, and urology specialties. All surgeons had previous laparoscopic MAS experience, while experience with robotics varied.Main outcomes measuresParticipants were scored on a five-point Likert Scale for each of six validated GEARS domains (depth perception, bimanual dexterity, efficiency, force sensitivity, autonomy, and robotic control). Additional metrics used to chart surgeon performance included: combined instrument path length; combined instrument angular path; and time taken to complete each task.ResultsParticipants demonstrated an overall improvement in performance during the study, with a mean GEARS Score of 21.0 (SD: 1.9) in Assessment 1 increasing to 23.4 (SD: 2.9) in Validation. Greatest improvements were observed in the depth perception and robotic control domains. Greatest differences were observed when stratifying by robotic experience; those with extensive experience consistently scored higher than those with some or no experience.ConclusionsThe Versius training program is effective; participants were able to successfully operate the system by program completion, and more surgeons achieved intermediate-level and expert-level GEARS scores in Validation compared with Assessment 1.

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