Colometer - A Real Time Quality Improvement Feedback System for Screening Colonoscopy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- %Clear
研究概览
简要总结
Our team has created an automated, real-time software based image analysis tool called Colometer to improve screening colonoscopy providing real time visual feedback on image quality. There are three components to this study. The first is to validate the bowel assessment preparation using the recorded colonoscopy videos from 50 consented normal risk patients. In the second phase, technological and machine user interface refinements will be identified and completed. Finally, the third phase will be a sham controlled prospective study of Colometer versus standard care in 100 consented average risk patients undergoing screening colonoscopy as performed by 10 consented endoscopists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients: patients categorized as normal risk who have been referred for screening colonoscopy at the Forzani & MacPhail Colon Cancer Screening Centre in Calgary, Alberta
- •Endoscopists: Gastroenterologists with practices at the Forzani & MacPhail Colon Cancer Screening Centre, Calgary, Alberta
排除标准
- •Patients: patients who are not categorized as normal risk
研究组 & 干预措施
Colometer
Colometer software will be engaged during the colonoscopy to provide real time feedback to the endoscopist.
干预措施: Colometer (Other)
Sham Software
An identical set-up to the experimental arm but with a green band showing across the top for the duration of the colonoscopy.
干预措施: Sham Software (Other)
Control
Recordings of colonoscopies made without Colometer or sham feedback during the course of the colonoscopy will be evaluated retrospectively using the Colometer software.
结局指标
主要结局
%Clear
时间窗: Measurement will occur during the withdrawal phase as indicated by the physician during the colonoscopy procedure; on average, 12 minutes
This is defined as the Percentage of the total withdrawal time where the withdrawal velocity is below a set speed limit and the view is clear (ie, not blurry) as measured by the software. Visualization of the colon lumen is ideal with a slow, non-blurry view in order to detect polyps.
次要结局
- Average withdrawal velocity(Measurement will occur during the withdrawal phase as indicated by the physician during the colonoscopy procedure; on average, 12 minutes.)
- Ottawa Stool Score(Measurement will occur during the withdrawal phase as indicated by the physician during the colonoscopy procedure; on average, 12 minutes.)
研究者
Christopher Andrews
Associate Professor
University of Calgary