Clinical trial NCT06112535: Prospective Clinical Study to Assess the Safety and Efficacy of Versius, in Transoral Robotic Surgery
Official title: Prospective Clinical Study to Assess the Safety and Efficacy of Versius, in Transoral Robotic Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Squamous Cell Carcinoma of the Oropharynx
Squamous Cell Carcinoma, Unknown Primary
Keywords: TORS
robotic surgery
transoral robotic surgery
Lead sponsor: CMR Surgical Ltd
Sponsor class: INDUSTRY
Collaborators: name: Liverpool University Hospitals NHS Foundation Trust
name: Sintesi Research S.r.l.
First posted: 2023-11-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Incidence rate of Adverse Events
timeFrame: Up to 30 days post operatively
measure: Rate of successful completion of TORS without conversion
timeFrame: Up to completion of surgery
Secondary outcomes:
measure: Operative time
timeFrame: Up to completion of surgery
measure: Incidence of Serious Adverse Events
timeFrame: Up to 30 days post operatively
measure: Blood loss
timeFrame: Up to completion of surgery
measure: Post-operative analgesic requirements in morphine equivalents
timeFrame: Up to post-surgery discharge (up to 30 days post-surgery)
measure: Length of stay
timeFrame: Up to discharge (up to 30 days post-surgery)
measure: Reoperation
timeFrame: Up to 30 days post operatively
measure: Device deficiencies and user errors
timeFrame: Up to completion of surgery
measure: Return to oral intake
timeFrame: Up to post-surgery discharge (up to 30 days post-surgery)
measure: Pathological margin
timeFrame: Up to 30 days post operatively
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Liverpool Head and Neck Centre, ENT Department Liverpool University Hospitals NHS Foundation Trust
Study officials:
affiliation: ENT Department Liverpool University Hospitals NHS Foundation Trust
name: Jason Fleming, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: