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| Name | Class |
|---|---|
| Liverpool University Hospitals NHS Foundation Trust | OTHER_GOV |
| Sintesi Research Srl | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TORS with Versius | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Versius Surgical System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of Adverse Events | To assess safety of TORS with Versius | Up to 30 days post operatively |
| Rate of successful completion of TORS without conversion | 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 | Up to completion of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | Time taken to complete surgery, excluding any reconstruction | Up to completion of surgery |
| Incidence of Serious Adverse Events | Incidence of Serious Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Fleming, MD PhD | ENT Department Liverpool University Hospitals NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liverpool Head and Neck Centre, ENT Department Liverpool University Hospitals NHS Foundation Trust | Liverpool | L9 7AL | United Kingdom |
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| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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|
| Up to 30 days post operatively |
| Blood loss | Estimated blood loss during surgery | Up to completion of surgery |
| Post-operative analgesic requirements in morphine equivalents | Pain medication taken post-surgery converted to morphine equivalents | Up to post-surgery discharge (up to 30 days post-surgery) |
| Length of stay | Length of post operative stay in hospital | Up to discharge (up to 30 days post-surgery) |
| Reoperation | Emergency re-operation after initial surgery | Up to 30 days post operatively |
| Device deficiencies and user errors | Device deficiencies and user errors | Up to completion of surgery |
| Return to oral intake | Amount of time after surgery before oral intake, including nasogastric tube requirement and length of use | Up to post-surgery discharge (up to 30 days post-surgery) |
| Pathological margin | Final pathological margin of resected specimens (mm) | Up to 30 days post operatively |
| D006258 |
| Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D018307 | Neoplasms, Squamous Cell |