Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-24 @ 10:40 PM
NCT ID:
NCT06112535
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06112535
Study Brief:
Protocol Section:
NCT06112535