Skip to main content
OpenTrials
Completed

NCT Number: NCT06112535

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Squamous Cell Carcinoma of the Oropharynx Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Squamous Cell Carcinoma of Head and Neck Squamous Cell Carcinoma, Unknown Primary

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Liverpool Head and Neck Centre, ENT Department Liverpool University Hospitals NHS Foundation Trust

Liverpool, L9 7AL, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Versius Surgical System

Device

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.

Primary outcomes

  1. Incidence rate of Adverse Events

    Time frame: Up to 30 days post operatively

    To assess safety of TORS with Versius

  2. Rate of successful completion of TORS without conversion

    Time frame: Up to completion of surgery

    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

Secondary outcomes

  1. Operative time

    Time frame: Up to completion of surgery

    Time taken to complete surgery, excluding any reconstruction

  2. Incidence of Serious Adverse Events

    Time frame: Up to 30 days post operatively

    Incidence of Serious Adverse Events

  3. Blood loss

    Time frame: Up to completion of surgery

    Estimated blood loss during surgery

  4. Post-operative analgesic requirements in morphine equivalents

    Time frame: Up to post-surgery discharge (up to 30 days post-surgery)

    Pain medication taken post-surgery converted to morphine equivalents

  5. Length of stay

    Time frame: Up to discharge (up to 30 days post-surgery)

    Length of post operative stay in hospital

  6. Reoperation

    Time frame: Up to 30 days post operatively

    Emergency re-operation after initial surgery

  7. Device deficiencies and user errors

    Time frame: Up to completion of surgery

    Device deficiencies and user errors

  8. Return to oral intake

    Time frame: Up to post-surgery discharge (up to 30 days post-surgery)

    Amount of time after surgery before oral intake, including nasogastric tube requirement and length of use

  9. Pathological margin

    Time frame: Up to 30 days post operatively

    Final pathological margin of resected specimens (mm)

Sponsors and collaborators

Lead sponsor

CMR Surgical Ltd

Industry

Collaborators

  • Liverpool University Hospitals NHS Foundation Trust
  • Sintesi Research Srl

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 1, 2023
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.