Assessing the safety and effectiveness of the Versius robotic system in throat surgery
Prospective Clinical Study to Assess the Safety and Efficacy of Versius, in Transoral Robotic Surgery
This study is testing if the Versius robotic system can safely and effectively help remove throat tumors in patients with cancer using minimally invasive surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CMR Surgical Ltd Industry-sponsored |
| Locations | 1 site (Liverpool) |
| Trial ID | NCT06112535 on ClinicalTrials.gov |
What this trial studies
This clinical study evaluates the safety and efficacy of the Versius Surgical System in performing transoral robotic surgery (TORS) for patients with squamous cell carcinoma of the oropharynx. It is a single-arm, multi-surgeon feasibility study conducted at a single site, focusing on patients who require surgical removal of cancerous tumors through minimally invasive techniques. The study aims to assess the rate of complications and the overall performance of the robotic system during surgery, with a follow-up period of 30 days post-operation. This will be one of the first in-human assessments of TORS using the Versius system.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over with histologically confirmed squamous cell carcinoma of the oropharynx or cervical lymph nodes without a discernible primary tumor.
Not a fit: Patients with T4 tumors or those for whom transoral surgery is not feasible due to anatomical or disease factors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective surgical option for patients with oropharyngeal cancer.
How similar studies have performed: Other studies have shown promise in robotic-assisted surgeries, but this specific application of the Versius system in TORS is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Liverpool
- Liverpool Head and Neck Centre, ENT Department Liverpool University Hospitals NHS Foundation Trust — Liverpool, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Jason Fleming, MD PhD — ENT Department Liverpool University Hospitals NHS Foundation Trust
- Study coordinator: Chad Schaber, PhD
- Email: chad.schaber@cmrsurgical.com
- Phone: +44 7864 922346
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.