Prospective Clinical Study to Assess the Safety and Efficacy of Versius, in Transoral Robotic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Rate of successful completion of TORS without conversion
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Disease / anatomical factors limiting access and freedom of operating using Versius Surgical System
- •Patients with distant metastatic disease as determined by pre-operative staging
- •UICC/AJCC TNM (7) stage N2c-N3 disease; TNM (8) N2-3 disease
- •American Society of Anaesthesiologists (ASA) Class IV or above
- •WHO Performance status 3 or above
- •Unwilling or unable to sign an informed consent form
- •Morbid Obesity (BMI ≥40)
- •Active pregnancy
- •Medical Contraindication for general anaesthesia
- •Patient participation in an interventional clinical study within 30 days prior to screening, and up to 45 days post-surgery
- •Patients with a history of radiotherapy to the head or neck
研究组 & 干预措施
TORS with Versius
干预措施: Versius Surgical System (Device)
结局指标
主要结局
Rate of successful completion of TORS without conversion
时间窗: 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
Incidence rate of Adverse Events
时间窗: Up to 30 days post operatively
To assess safety of TORS with Versius
次要结局
- Incidence of Serious Adverse Events(Up to 30 days post operatively)
- Blood loss(Up to completion of surgery)
- Operative time(Up to completion of surgery)
- Pathological margin(Up to 30 days post operatively)
- Post-operative analgesic requirements in morphine equivalents(Up to post-surgery discharge (up to 30 days post-surgery))
- Length of stay(Up to discharge (up to 30 days post-surgery))
- Device deficiencies and user errors(Up to completion of surgery)
- Return to oral intake(Up to post-surgery discharge (up to 30 days post-surgery))
- Reoperation(Up to 30 days post operatively)