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临床试验/NCT03458403
NCT03458403已完成不适用

Endoscopist and Endoscope Motions During Digestive Endoscopy

IHU Strasbourg2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2018年8月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
23
试验地点
2
主要终点
Body motions recording

研究概览

简要总结

The aim of the study is to record and analyze endoscopist and endoscope motions to identify key movements in flexible endoscopy.

详细描述

The increasing development of interventional digestive endoscopy raises the challenge to teach and learn complex endoscopic procedures. Nowadays experts are facing the challenge of explaining precisely an elaborate choreography of movements performed during the procedure, while novices are confronted with a broad range of hand, wrist and shoulder movements each resulting in different endoscope responses. The teaching strategy of endoscopy could benefit from a dedicated motion library that would associate the endoscopist's motion and the consequent endoscope response. A simplified endoscopic language made of individual motions could greatly shorten the learning curve.

The aim of the study is to record and analyze endoscopist and endoscope motions to identify key movements in flexible endoscopy.

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

入选标准

  • Patient over 18 years old
  • Patient who are scheduled for a gastroscopy procedure under sedation
  • Patient able to understand the study and provide written informed consent
  • Patient affiliated to the French social security system.

排除标准

  • Patient with an altered upper GI anatomy due to previous surgery
  • Patient with a known anomaly of the upper GI anatomy
  • Patient carrying an implantable medical device (pacemaker...)
  • Patient with a condition preventing its participation to study procedures, according to investigator's judgment
  • Pregnancy or breastfeeding
  • Patient in custody
  • Patient under guardianship

结局指标

主要结局

Body motions recording

时间窗: At time of endoscopy

Body motions recording using the Xsens tracking device. The Xsens motion tracking system consists of 17 wireless motion sensors that are applied with straps to the endoscopist without hindering natural movements.

Endoscope wheels rotation recording

时间窗: At time of endoscopy

External video recording of the endoscope wheels rotation.

Endoscope motions recording

时间窗: At time of endoscopy

Endoscope motions recording using the Aurora electromagnetic tracking system (NDI, Waterloo, Canada) inserted in the endoscope operating channel. The Aurora electromagnetic tracking system is designed for tracking tip and orientation of rigid and flexible endoscopes. The system consists of an electromagnetic field generator and a probe carrying the captors.

Endoluminal images recording

时间窗: At time of endoscopy

Endoluminal images recording using the endoscopic camera.

次要结局

未报告次要终点

研究者

发起方
IHU Strasbourg
申办方类型
Other
责任方
Sponsor

研究点 (2)

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