跳至主要内容
临床试验/NCT01464918
NCT01464918Unknown不适用

Safety and Efficacy of Using MASTER, a Novel Robotics Enhanced Endosurgical System to Perform Endoscopic Submucosal Dissection in Human

National University Hospital, Singapore5 个研究点 分布在 3 个国家目标入组 7 人开始时间: 2011年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
7
试验地点
5
主要终点
Total time taken to complete the ESD procedure

研究概览

简要总结

This trial is to evaluate the safety and efficacy of using MASTER, a robotics enhanced endosurgical system to perform endoscopic submucosal dissection (ESD) of gastric/colon cancer in human.

详细描述

This trial is to evaluate the safety and efficacy of using MASTER, a novel robotics enhanced endosurgical system to perform endoscopic submucosal dissection (ESD) of gastric/colon cancer in human. The MASTER is a master-and-slave robotic system that is deployed through a standard dual-channel therapeutic endoscope. It introduces robotic control of endoscopic surgical tools and tasks through an ergonomic human-machine interface built around the original endoscopic paradigm. In doing so, it separates control of instrumental motion from that of endoscopic movement such that surgical tasks may be independently executed by a second operator via a human-machine interface. With it, endoscopically deployed instruments can be independently controlled, allowing thus bimanual coordination of effector instruments to facilitate actions such as retraction/exposure, traction/countertraction, approximation and dissection of tissue. Using the MASTER, operational dexterity is increased, thus making it easier for the operator to perform the ESD procedure as compared with using the conventional endoscope. This study will measure the ease of using the MASTER to perform the various surgical tasks involved in the ESD procedure, the time taken to perform the procedure, and record complications, if any, occurred during and after 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
21 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patient diagnosed with early gastric or colon cancer, is deemed suitable to undergo endoscopic submucosal dissection and is able/willing to give informed consent.

排除标准

  • case is deemed not suitable for endoscopic submucosal dissection
  • is on warfarin or other blood thinning agents and those with bleeding disorders
  • has uncorrected coagulopathy or severe thrombocytopenia precluding biopsy
  • has serious co-morbidities such as heart disease, renal impairment and cancer
  • has recently underwent surgery or has a personal history of stomach/colon cancer or surgery
  • is unable/unwilling to give informed consent
  • is pregnant or breast-feeding women patients who cannot undergo gastroscopies

结局指标

主要结局

Total time taken to complete the ESD procedure

时间窗: Participants will be followed for the duration of the operation, an expected average of 3 hours

The total time spent from docking of MASTER to end of submucosal dissection

次要结局

  • Measure of ease of performing the ESD procedure(Participants will be followed for the duration of the operation, an expected average of 3 hours)
  • Safety(From start of operation of the ESD procedure, assessed up to 7 days after the procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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