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

CMR Surgical

Status: Enrolling

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

Treatments: Device: Versius Surgical System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06112535

CA-00388

Details and patient eligibility

About

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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

TORS with Versius

Experimental group

Treatment:

Device: Versius Surgical System