Prospective Clinical Study to Assess the Safety and Efficacy of Versius, in Transoral Robotic Sur… (NCT06112535) | Clinical Trial Compass
CompletedNot Applicable
Prospective Clinical Study to Assess the Safety and Efficacy of Versius, in Transoral Robotic Surgery
United Kingdom60 participantsStarted 2023-12-13
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patient and disease factors deemed suitable for Robotic-Assisted Trans Oral Robotic Surgery (TORS) procedure using the Versius Surgical System
✓. Aged 18 or over with signed, written informed consent
✓. 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)
✓. Patients considered fit for surgery and potential adjuvant treatment (WHO performance status 0-2)
✓. Multidisciplinary team (MDT) decision to treat with primary surgery
✓. Surgical site and anatomical factors allowing access and freedom of operating using Versius Surgical System
Exclusion criteria
✕. 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
What they're measuring
1
Incidence rate of Adverse Events
Timeframe: Up to 30 days post operatively
2
Rate of successful completion of TORS without conversion