Endoscopic Submucosal Dissection (ESD)- Master Slave Robotic System - Human Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Ease of the procedure
研究概览
简要总结
The purpose of this study is to evaluate the feasibility, ease and safety of flexible endoscopic robotic system to treat early gastric cancer in humans.
详细描述
Aim:
To evaluate the feasibility and safety of Endoscopic Submucosal Dissection (ESD) using Master Slave Endoscopic Robotic System in humans.
Material and Methods:
To assess the feasibility and safety of ESD in humans, 3 patients with early gastric cancer or sessile polyp in the stomach with no evidence of involvement of deeper layer will be included in the study. The depth of involvement is evaluated by endoscopic ultrasound. An informed consent about the nature of the procedure, complications and the need for surgery will be explained to the patient. The master slave robot system (Human master robotic interface, telesurgical workstation and slave manipulator) and forward viewing therapeutic endoscope with 2 operating channels (GIF -2T160) will be used. The master controller controls the slave manipulator with electrical cables through a software interface. The slave manipulator in turn controls the end effectors (Monopolar 'L' hook and grasper) through cables passed through the two operating channels of the endoscope. The master slave robot system will be set up by the engineers from the Nanyang Technological University, Singapore. The endoscope will be connected to the high definition visual display and will be recorded throughout the procedure. Another high definition monitor will be set up for the surgeon/endoscopist who will control the MASTER at the console and the movements at the console will be continuously recorded. Monopolar electrocautery (ERBE) will be set up and tested. The settings for cutting and blend will be the same as used in the conventional ESD.
The therapeutic endoscope and the end effectors will be sterilised by immersing the scope in glutaraldehyde for 30 minutes before the procedure.
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
- 25 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Early Gastric Cancer or Gastric sessile polyp with dysplasia
排除标准
- •Gastric Cancer with involvement of muscle layer
- •Advanced Gastric cancer
研究组 & 干预措施
ESD using MASTER Slave Robotic System
干预措施: ESD using Master Slave Robotic System (Device)
结局指标
主要结局
Ease of the procedure
时间窗: 30 days
The ease of the procedure (grasping, retraction, triangulation), time required for mucosal cutting and submucosal dissection
次要结局
- Immediate Procedure Related Complications(30 days)
- Delayed Procedure Related Complications(30 days)
- Completeness of the Procedure(30 days)
