Prospective Clinical Study to Assess the Safety and Efficacy of Versius, in Transoral Robotic Surgery
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TORS with Versius
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Device: Versius Surgical System
Transoral robotic surgery (TORS) using Versius Surgical System. Versius is a robot designed to help surgeons perform surgery. It consists of a set of robotic arms: one of the arms has a camera and a light source on it while the other arms each have a small surgical instrument attached at the end. The surgeon controls each of the arms with hand controllers (joysticks) and can perform surgery with them, while seeing the surgical area on a screen in front of him/her.
The camera and instruments are inserted into the mouth and throat in order to cut out a cancerous tumour.
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Outcome Measures
Primary Outcome Measures
- Incidence rate of Adverse Events [Up to 30 days post operatively]
To assess safety of TORS with Versius
- Rate of successful completion of TORS without conversion [Up to completion of surgery]
To assess efficacy of TORS with Versius by the rate of successful completion of Transoral Robotic Surgery (TORS) without unplanned conversion to other transoral or open techniques
Secondary Outcome Measures
- Operative time [Up to completion of surgery]
Time taken to complete surgery, excluding any reconstruction
- Incidence of Serious Adverse Events [Up to 30 days post operatively]
Incidence of Serious Adverse Events
- Blood loss [Up to completion of surgery]
Estimated blood loss during surgery
- Post-operative analgesic requirements in morphine equivalents [Up to post-surgery discharge (up to 30 days post-surgery)]
Pain medication taken post-surgery converted to morphine equivalents
- Length of stay [Up to discharge (up to 30 days post-surgery)]
Length of post operative stay in hospital
- Reoperation [Up to 30 days post operatively]
Emergency re-operation after initial surgery
- Device deficiencies and user errors [Up to completion of surgery]
Device deficiencies and user errors
- Return to oral intake [Up to post-surgery discharge (up to 30 days post-surgery)]
Amount of time after surgery before oral intake, including nasogastric tube requirement and length of use
- Pathological margin [Up to 30 days post operatively]
Final pathological margin of resected specimens (mm)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient and disease factors deemed suitable for Robotic-Assisted Trans Oral Robotic Surgery (TORS) procedure using the Versius Surgical System
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Aged 18 or over with signed, written informed consent
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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)
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Patients considered fit for surgery and potential adjuvant treatment (WHO performance status 0-2)
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Multidisciplinary team (MDT) decision to treat with primary surgery
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Surgical site and anatomical factors allowing access and freedom of operating using Versius Surgical System
Exclusion Criteria:
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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
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Disease / anatomical factors limiting access and freedom of operating using Versius Surgical System
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Patients with distant metastatic disease as determined by pre-operative staging
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UICC/AJCC TNM (7) stage N2c-N3 disease; TNM (8) N2-3 disease
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American Society of Anaesthesiologists (ASA) Class IV or above
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WHO Performance status 3 or above
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Unwilling or unable to sign an informed consent form
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Morbid Obesity (BMI ≥40)
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Active pregnancy
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Medical Contraindication for general anaesthesia
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Patient participation in an interventional clinical study within 30 days prior to screening, and up to 45 days post-surgery
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Patients with a history of radiotherapy to the head or neck
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Liverpool Head and Neck Centre, ENT Department Liverpool University Hospitals NHS Foundation Trust | Liverpool | United Kingdom | L9 7AL |
Sponsors and Collaborators
- CMR Surgical Ltd
- Liverpool University Hospitals NHS Foundation Trust
- Sintesi Research S.r.l.
Investigators
- Principal Investigator: Jason Fleming, MD PhD, ENT Department Liverpool University Hospitals NHS Foundation Trust
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CA-00388