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).

Study Overview

• Status: Recruiting
• Conditions: Squamous Cell Carcinoma of the Oropharynx; Squamous Cell Carcinoma, Unknown Primary
• Intervention / Treatment: Device: Versius Surgical System

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chad Schaber, PhD; Phone Number: +44 7864 922346; Email: chad.schaber@cmrsurgical.com
• Study Contact Backup: Name: Morad Nakhleh, PhD; Phone Number: +44 7518 295217; Email: morad.nakhleh@cmrsurgical.com

Study Locations

• United Kingdom
  • Liverpool, United Kingdom, L9 7AL
    • Recruiting
    • Liverpool Head and Neck Centre, ENT Department Liverpool University Hospitals NHS Foundation Trust
    • Contact: Jason Fleming, MD PhD; Phone Number: +44 151 5295259; Email: jason.fleming@liverpool.ac.uk
    • Sub-Investigator: Christopher Loh, MD
    • Sub-Investigator: Katharine Davies, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: TORS with Versius

Device: Versius Surgical System; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: CMR Surgical Ltd
• Collaborators: Liverpool University Hospitals NHS Foundation Trust; Sintesi Research S.r.l.
• Investigators: Principal Investigator: Jason Fleming, MD PhD, ENT Department Liverpool University Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: October 27, 2023
• First Posted (Actual): November 1, 2023

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: robotic surgery; transoral robotic surgery; TORS
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell
• Other Study ID Numbers: CA-00388

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No