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

Not Applicable

Recruiting

• Conditions: Squamous Cell Carcinoma of the Oropharynx; Squamous Cell Carcinoma, Unknown Primary
• Interventions: Device: Versius Surgical System

• Registration Number: NCT06112535
• Lead Sponsor: CMR Surgical Ltd

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-23
• Study First Submitted QC: 2023-10-27
• Study First Posted: 2023-11-01
• Study Start: 2023-12-13
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-03-18
• Primary Completion: 2024-12
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TORS with Versius	Versius Surgical System	-

Primary Outcome Measures

Name	Time	Method
Rate of successful completion of TORS without conversion	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
Incidence rate of Adverse Events	Up to 30 days post operatively	To assess safety of TORS with Versius

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Liverpool Head and Neck Centre, ENT Department Liverpool University Hospitals NHS Foundation Trust; 🇬🇧 Liverpool, United Kingdom