NCT01029899已完成不适用
Phase II Study of Evaluation of Handheld Colonoscopy Force Monitor by Expert and Trainee Endoscopists in the Performance of Colonoscopy
Artann Laboratories2 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2009年12月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 153
- 试验地点
- 2
- 主要终点
- Colonoscopy Force Monitoring demonstrates patterns of how doctors in training are different from very experienced doctors when they do colonoscopy.
研究概览
简要总结
The study is to evaluate how doctors in training are different from very experienced doctors when using force to perform colonoscopy with a device that monitors the amount of force applied to the colonoscope during colonoscopy.
详细描述
The study consists of two sequential observational studies designed to identify which instrument should be used to assess trainee performance and to quantify trainee skill development in performance of colonoscopy over the course of their training program.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing diagnostic or screening colonoscopy ASA Class I or II
- •All ethnic and racial groups will be included
- •Able to comprehend, sign and date the written informed consent form (ICF)
- •English is their primary language
排除标准
- •Chronic pathology that in the opinion of the endoscopist could interfere with the colonoscopy. Examples include: colonic stricture, poor preparation, obstructing tumor
- •Specific pathology that would limit the extent of examination
- •ASA class 3 or greater
- •Pregnancy
- •Vulnerable subjects. Students, nursing home residents, institutionalized patients, and those with psychological or physical incapacity
结局指标
主要结局
Colonoscopy Force Monitoring demonstrates patterns of how doctors in training are different from very experienced doctors when they do colonoscopy.
时间窗: 18 months
次要结局
未报告次要终点
研究者
研究点 (2)
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