Status:
COMPLETED
Prospective Clinical Study to Assess the Safety and Efficacy of Versius, in Transoral Robotic Surgery
Lead Sponsor:
CMR Surgical Ltd
Collaborating Sponsors:
Liverpool University Hospitals NHS Foundation Trust
Sintesi Research S.r.l.
Conditions:
Squamous Cell Carcinoma of the Oropharynx
Squamous Cell Carcinoma, Unknown Primary
Eligibility:
All Genders
18+ years
Phase:
NA
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 hel...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 22 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06112535
Start Date
December 13 2023
End Date
April 22 2025
Last Update
June 25 2025
Active Locations (1)
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1
Liverpool Head and Neck Centre, ENT Department Liverpool University Hospitals NHS Foundation Trust
Liverpool, United Kingdom, L9 7AL