跳至主要内容
临床试验/NCT07691580
NCT07691580招募中不适用

Evaluation of Biomechanical Forced During the Practice of Endoscopic Retrograde Cholangiopancreatography

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2026年6月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
10
试验地点
1
主要终点
measurement of average muscle during ERCP

研究概览

简要总结

A number of best practice recommendations have been developed to improve practitioner comfort, similar to those recommended for digestive surgeons. It is recommended to use a height-adjustable examination table, position the screen at eye level, and use a chair during the procedure. The use of lead aprons is essential for certain endoscopic procedures (ERCP drainage of the bile ducts, prosthesis placement, etc.). Several retrospective studies in the surgical and radiological fields have shown an increased risk of MSDs among these populations. To distribute the weight of the apron, several shapes are available to limit stress. An apron weighs approximately 7 kg, due in particular to the amount of lead. The aim of this study is to evaluate the biomechanical forced experienced by the gastroenterologist during ERCP.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

  • Adult subject (age ≥ 18 years)
  • hepato-gastroenterologist
  • Performing ERCP
  • Person who has given consent for participation in the study

排除标准

  • 未提供

研究组 & 干预措施

CAPTIV system

Experimental

• Each practitioner will perform 4 ERCP recorded using the CAPTIV system. In order to know the biomechanical constraints during standard endoscopic examination (upper endoscopy and colonoscopy), an upper endoscopy and a standard colonoscopy examination will also be filmed and monitored.

干预措施: CAPTIV system (Device)

结局指标

主要结局

measurement of average muscle during ERCP

时间窗: 1 day

measurement of average muscle during ERCP

measurement of angular analysis during ERCP

时间窗: day 1

次要结局

  • level of stress during the practice of ERCP(day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验