Prospective Clinical Study to Assess the Safety and Efficacy of Versius, in Transoral Robotic Surgery

Study Overview
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Brief Summary
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This is a single-arm, single site, multi-surgeon prospective feasibility study for transoral robot assisted surgery (TORS) with the Versius Surgical System. Versius is a robotic system designed to help in the accurate control of surgical instruments for minimal access (keyhole) surgery. In TORS procedures surgical instruments are inserted through the mouth/throat to remove sick tissue rather than through skin incisions. The primary objective of this study will be to evaluate the safe use and performance of the Versius in transoral surgeries. Pre-clinical work has been conducted to ensure TORS with Versius is viable and safe; this will be one of the first in-human studies of TORS with Versius. This study will focus specifically on patients with cancerous tumours of the oropharynx (the mouth/throat) that need to be surgically removed. The safety of Versius for TORS will be mainly assessed by the rate of complications/adverse events up to 30 days after surgery, and the performance will be mainly assessed by the number of TORS cases successfully completed with Versius (i.e. without having to switch to another surgical technique).

Official Title
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Prospective Clinical Study to Assess the Safety and Efficacy of Versius, in Transoral Robotic Surgery

Conditions
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Squamous Cell Carcinoma of the Oropharynx, Squamous Cell Carcinoma, Unknown Primary

Intervention / Treatment
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* Device: Versius Surgical System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient and disease factors deemed suitable for Robotic-Assisted Trans Oral Robotic Surgery (TORS) procedure using the Versius Surgical System Aged 18 or over with signed, written informed consent Histologically confirmed squamous cell carcinoma of the oropharynx {UICC/AJCC TNM (7) stage T1-3, N0-N2b / TNM (8) T1-3, N0-1 disease} OR Histologically confirmed squamous cell carcinoma in 1 or more cervical lymph nodes, with no discernible primary tumour (cancer unknown primary) Patients considered fit for surgery and potential adjuvant treatment (WHO performance status 0-2) Multidisciplinary team (MDT) decision to treat with primary surgery Surgical site and anatomical factors allowing access and freedom of operating using Versius Surgical System Exclusion Criteria: T4 tumours, or T1-T3 where transoral surgery is not considered feasible due to anatomy, location, or disease factors; these may include (but not limited to) tumour visualisation, endophytic growth pattern and resulting defect functional concerns Disease / anatomical factors limiting access and freedom of operating using Versius Surgical System Patients with distant metastatic disease as determined by pre-operative staging UICC/AJCC TNM (7) stage N2c-N3 disease; TNM (8) N2-3 disease American Society of Anaesthesiologists (ASA) Class IV or above WHO Performance status 3 or above Unwilling or unable to sign an informed consent form Morbid Obesity (BMI ≥40) Active pregnancy Medical Contraindication for general anaesthesia Patient participation in an interventional clinical study within 30 days prior to screening, and up to 45 days post-surgery Patients with a history of radiotherapy to the head or neck

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TORS with Versius<br> | Device: Versius Surgical System<br>* Transoral robotic surgery (TORS) using Versius Surgical System. Versius is a robot designed to help surgeons perform surgery. It consists of a set of robotic arms: one of the arms has a camera and a light source on it while the other arms each have a small surgical instrument attached at the end. The surgeon controls each of the arms with hand controllers (joysticks) and can perform surgery with them, while seeing the surgical area on a screen in front of him/her. The camera and instruments are inserted into the mouth and throat in order to cut out a cancerous tumour.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of Adverse Events | To assess safety of TORS with Versius | Up to 30 days post operatively | 
| Rate of successful completion of TORS without conversion | To assess efficacy of TORS with Versius by the rate of successful completion of Transoral Robotic Surgery (TORS) without unplanned conversion to other transoral or open techniques | Up to completion of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time | Time taken to complete surgery, excluding any reconstruction | Up to completion of surgery | 
| Incidence of Serious Adverse Events | Incidence of Serious Adverse Events | Up to 30 days post operatively | 
| Blood loss | Estimated blood loss during surgery | Up to completion of surgery | 
| Post-operative analgesic requirements in morphine equivalents | Pain medication taken post-surgery converted to morphine equivalents | Up to post-surgery discharge (up to 30 days post-surgery) | 
| Length of stay | Length of post operative stay in hospital | Up to discharge (up to 30 days post-surgery) | 
| Reoperation | Emergency re-operation after initial surgery | Up to 30 days post operatively | 
| Device deficiencies and user errors | Device deficiencies and user errors | Up to completion of surgery | 
| Return to oral intake | Amount of time after surgery before oral intake, including nasogastric tube requirement and length of use | Up to post-surgery discharge (up to 30 days post-surgery) | 
| Pathological margin | Final pathological margin of resected specimens (mm) | Up to 30 days post operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TORS, robotic surgery, transoral robotic surgery