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

NCT06112535 | Completed

• 1 other identifier: CA-00388
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

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

Keywords

TORS; robotic surgery; transoral robotic surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Operative time

  Up to completion of surgery

• Incidence of Serious Adverse Events

  Up to 30 days post operatively

• Blood loss

  Up to completion of surgery

• Post-operative analgesic requirements in morphine equivalents

  Up to post-surgery discharge (up to 30 days post-surgery)

• Length of stay

  Up to discharge (up to 30 days post-surgery)

Study Arms (1)

TORS with Versius

EXPERIMENTAL

Device: Versius Surgical System

Interventions

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.

TORS with Versius

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CMR Surgical Ltd: lead
• Liverpool University Hospitals NHS Foundation Trust: collaborator
• Sintesi Research S.r.l.: collaborator

Study Sites (1)

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

Liverpool, L9 7AL, United Kingdom

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms, Squamous Cell

Study Officials

• Jason Fleming, MD PhD

  ENT Department Liverpool University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: November 1, 2023
• Study Start: December 13, 2023
• Primary Completion: April 16, 2025
• Study Completion: April 22, 2025
• Last Updated: June 25, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)