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

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

NCT ID: NCT06112535

Condition: Squamous Cell Carcinoma of the Oropharynx
Squamous Cell Carcinoma, Unknown Primary

Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell

Conditions: Keywords:
TORS
robotic surgery
transoral robotic surgery

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: Versius Surgical System
Description: 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.
Arm group label: TORS with Versius

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).

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Patient and disease factors deemed suitable for Robotic-Assisted Trans Oral Robotic Surgery (TORS) procedure using the Versius Surgical System 2. Aged 18 or over with signed, written informed consent 3. 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) 4. Patients considered fit for surgery and potential adjuvant treatment (WHO performance status 0-2) 5. Multidisciplinary team (MDT) decision to treat with primary surgery 6. Surgical site and anatomical factors allowing access and freedom of operating using Versius Surgical System Exclusion Criteria: 1. 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 2. Disease / anatomical factors limiting access and freedom of operating using Versius Surgical System 3. Patients with distant metastatic disease as determined by pre-operative staging 4. UICC/AJCC TNM (7) stage N2c-N3 disease; TNM (8) N2-3 disease 5. American Society of Anaesthesiologists (ASA) Class IV or above 6. WHO Performance status 3 or above 7. Unwilling or unable to sign an informed consent form 8. Morbid Obesity (BMI ≥40) 9. Active pregnancy 10. Medical Contraindication for general anaesthesia 11. Patient participation in an interventional clinical study within 30 days prior to screening, and up to 45 days post-surgery 12. Patients with a history of radiotherapy to the head or neck

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

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

Address:
City: Liverpool
Zip: L9 7AL
Country: United Kingdom

Status: Recruiting

Contact:
Last name: Jason Fleming, MD PhD

Phone: +44 151 5295259
Email: jason.fleming@liverpool.ac.uk

Investigator:
Last name: Christopher Loh, MD
Email: Sub-Investigator

Investigator:
Last name: Katharine Davies, MD
Email: Sub-Investigator

Start date: December 13, 2023

Completion date: February 2025

Lead sponsor:
Agency: CMR Surgical Ltd
Agency class: Industry

Collaborator:
Agency: Liverpool University Hospitals NHS Foundation Trust
Agency class: Other

Collaborator:
Agency: Sintesi Research S.r.l.
Agency class: Other

Source: CMR Surgical Ltd

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06112535