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临床试验/NCT04263818
NCT04263818已完成不适用

Étude du Mouvement de l'opérateur et de l'Endoscope au Cours de la Coloscopie

IHU Strasbourg1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2020年6月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
12
试验地点
1
主要终点
Endoscope 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 during colonoscopy.

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 during colonoscopy.

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

  • •Patient male or female
  • •Patient over 18 years old
  • •Patient who are scheduled for a colonoscopy 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 unable to provide a written informed consent
  • •Patient with an altered colonic anatomy due to previous surgery
  • •Patient with a known anomaly of the colon
  • •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

研究组 & 干预措施

Motions during colonoscopy

Experimental

Recording of endoscopist and endoscope motions right after the endoscopic exam the patient came for

干预措施: Recording of endoscopist and endoscope motions right after the endoscopic exam the patient came for (Procedure)

结局指标

主要结局

Endoscope motions recording

时间窗: At time of colonoscopy

Endoscope motions recording using the ScopeGuide tracking system. Real-time visualization of the ScopeGuide system is possible thanks to integrated electromagnetic coils and an external sensor that generate a 3D representation of the colonoscope next to the endoscopic image.

Endoscope wheels rotation recording

时间窗: At time of colonoscopy

External video recording of the endoscope wheels rotation

Body motions recording

时间窗: At time of colonoscopy

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.

Endoluminal images recording

时间窗: At time of colonoscopy

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 (1)

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Endoscopist and Endoscope Motions During Colonoscopy | 临床试验