Pre‐clinical evaluation of a novel robotic system for transoral robotic surgery

Faulkner, Jack; Arora, Asit; Swords, Chloe; Cook, Emma; Rajangam, Akshaya; Jeannon, Jean Pierre

doi:10.1111/coa.13740

Cited by 5 publications

(12 citation statements)

References 14 publications

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“…During the previously published feasibility cadaver studies, significant tremor of the instrument and endoscope arms was experienced when the operating surgeon activated that arm 18. Four solutions to address this issue were undertaken.…”

Section: Resultsmentioning

confidence: 99%

“…The Versius Surgical System is usually deployed through laparoscopic ports into a visceral cavity. Initial trials suggested that when applied transorally, without laparoscopic ports, the instruments suffered from significant tremor 18. Optimisation of BSU and VPP placements combined with system developments has reduced the number of instrument arm clashes and addressed this limitation.…”

Section: Discussionmentioning

confidence: 99%

“…The system has proved to be safe and effective in these applications and is in clinical use in general surgery, urology, gynaecology and thoracic surgery. Initial feasibility of the Versius Surgical System for use in TORS and also robotic access to the nasopharynx and anterior skull base via a combined transorbital and transnasal approach has been previously reported by our group 5 18…”

Section: Introductionmentioning

confidence: 91%

“…The initial feasibility work conducted a three cadaver evaluation using two expert TORS surgeons 18. This study aims to build on initial feasibility work and conduct a preclinical evaluation that evaluates and optimises the Versius surgical system for clinical study in TORS.…”

Section: Introductionmentioning

confidence: 99%

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New robotic platform for transoral robotic surgery: an IDEAL stage 0 study

Arora,

Faulkner,

Paleri

et al. 2024

BMJ Surg Interv Health Technologies

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ObjectivesThis study aims to assess the feasibility to perform transoral robotic surgery (TORS) with a new robotic platform, the Versius Surgical System (CMR Surgical, UK) in a preclinical cadaveric setting in accordance to stage 0 of the IDEAL-D framework.DesignIDEAL stage 0 preclinical assessment of the Versius Robotic System in TORS in human cadavers.SettingAll procedures were performed in a simulated operating theatre environment at a UK surgical training centre.Participants11 consultant head and neck surgeons from the UK, mainland Europe and the USA took part in TORS procedures on six human cadavers.Interventions3 key index procedures were assessed that represent the core surgical workload of TORS: lateral oropharyngectomy, tongue base resection and partial supraglottic laryngectomy.Main outcome measuresThe primary outcome was the successful completion of each surgical procedure. Secondary outcomes included the optimisation of system setup, instrumentation and surgeon-reported outcomes for feasibility of each component procedural step.Results33 cadaveric procedures were performed and 32 were successfully completed. One supraglottic laryngectomy was not fully completed due to issues dividing the epiglottic cartilage with available instrumentation. Surgeon-reported outcomes met the minimal level of feasibility in all procedures and a consensus that it is feasible to perform TORS with Versius was reached. Available instrumentation was not representative of other robotic platforms used in TORS and further instrument optimisation is recommended before wider dissemination.ConclusionsIt is feasible to perform TORS with the Versius Surgical System (CMR Surgical) within a pre-clinical cadaveric setting. Clinical evaluation is needed and appropriate with the system. Further instrument development and optimisation is desirable.

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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 91%

Section: Introductionmentioning

confidence: 99%

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New robotic platform for transoral robotic surgery: an IDEAL stage 0 study

Arora,

Faulkner,

Paleri

et al. 2024

BMJ Surg Interv Health Technologies

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“…Versius is not currently CE marked or FDA approved for use within the head and neck and has not been clinically tested in this environment. Our study team has conducted pre-clinical dry lab and cadaveric evaluation of the system for transoral use completing a stage 0 assessment in accordance with the IDEAL framework of surgical innovation and concluded that clinical assessment of the system is appropriate however further development of instrumentation would be desired for wider clinical dissemination [ 7 , 13 ].…”

Section: Introductionmentioning

confidence: 99%

Prospective development study of the Versius Surgical System for use in transoral robotic surgery: an IDEAL stage 1/2a first in human and initial case series experience

Faulkner,

Arora,

McCulloch

et al. 2024

Eur Arch Otorhinolaryngol

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Purpose Transoral robotic surgery is well established in the treatment paradigm of oropharyngeal pathology. The Versius Surgical System (CMR Surgical) is a robotic platform in clinical use in multiple specialities but is currently untested in the head and neck. This study utilises the IDEAL framework of surgical innovation to prospectively evaluate and report a first in human clinical experience and single centre case series of transoral robotic surgery (TORS) with Versius. Methods Following IDEAL framework stages 1 and 2a, the study evaluated Versius to perform first in human TORS before transitioning from benign to malignant cases. Iterative adjustments were made to system setup, instrumentation, and technique, recorded in accordance with IDEAL recommendations. Evaluation criteria included successful procedure completion, setup time, operative time, complications, and subjective impressions. Further evaluation of the system to perform four-arm surgery was conducted. Results 30 TORS procedures were successfully completed (15 benign, 15 malignant) without intraoperative complication or conversion to open surgery. Setup time significantly decreased over the study period. Instrumentation challenges were identified, urging the need for TORS-specific instruments. The study introduced four-arm surgery, showcasing Versius’ unique capabilities, although limitations in distal access were observed. Conclusions TORS is feasible with the Versius Surgical System. The development of TORS-specific instruments would benefit performance and wider adoption of the system. 4-arm surgery is possible however further evaluation is required. Multicentre evaluation (IDEAL stage 2b) is recommended.

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Robotic Transorbital Surgery: Concepts and Future Directions

Roh

2024

Endoscopic Transorbital Surgery of the Orbit, Skull Base and Brain

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Pre‐clinical evaluation of a novel robotic system for transoral robotic surgery

Cited by 5 publications

References 14 publications

New robotic platform for transoral robotic surgery: an IDEAL stage 0 study

New robotic platform for transoral robotic surgery: an IDEAL stage 0 study

Prospective development study of the Versius Surgical System for use in transoral robotic surgery: an IDEAL stage 1/2a first in human and initial case series experience

Robotic Transorbital Surgery: Concepts and Future Directions

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