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临床试验/NCT01394861
NCT01394861已完成早期 1 期

Endoscopic Submucosal Dissection (ESD)- Master Slave Robotic System - Human Study

Asian Institute of Gastroenterology, India2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2011年6月1日最近更新:
适应症
干预措施

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

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

Experimental

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)

研究者

发起方
Asian Institute of Gastroenterology, India
申办方类型
Other
责任方
Sponsor

研究点 (2)

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