Safety and Feasibility Study of the Foot Controlled Robotic Endoscope Enabled Robot (FREE) in Functional Endoscopic Sinus Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Conversion
研究概览
简要总结
To evaluate the safety and feasibility of a Foot Controlled Robotic Endoscope Enabled Robot (FREE) in performing functional endoscopic sinus surgery to answer the two key questions:
- Is the FREE robot feasible to use in patients for endoscopic sinus surgery?
- Is the FREE robot safe to use in patients for endoscopic sinus surgery?
详细描述
Through previous cadaver experiments we have demonstrated and experimentally validated a new foot-controlled robotic endoscope holder prototype that allows the surgeon to directly manipulate surgical instruments with both hands at all times. The conducted ex-vivo cadaver test, corroborated the feasibility of the robotic prototype. However the next step requires further clinical trials to evaluate its use in endoscopic sinus surgery in patients that is the purpose of this study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Undergoing FESS surgery for benign pathology
排除标准
- •Pregnant/ lactating female patients
- •Younger than 18 years of age
- •Cognitive impairment or unable to provide informed consent
- •Malignant sinus pathologies
- •Previous endoscopic sinus surgery
- •Contraindication to general anaesthesia
- •Untreated active infection
- •Non-correctable coagulopathy
- •Emergency Surgery
研究组 & 干预措施
FREE robot
Patients undergoing sinus surgery with the FREE robot
干预措施: FREE robot (Device)
结局指标
主要结局
Conversion
时间窗: Intraoperative
The rate of conversions to normal holding of the endoscope
Perioperative complications
时间窗: Within 30 days postoperative
Assessment of perioperative complications
次要结局
- Surgical Outcomes(Intraoperative and postoperative 2 weeks and 30 days)
- Quality of life(Within 30 days postoperative)
- Surgical outcomes(Intraoperative and postoperative 2 weeks and 30 days)
研究者
Jason Chan
Assistant Professor
Chinese University of Hong Kong