Collecting Recorded Videos of Colonoscopy Screening Tests for the Evaluation of the Automatic Polyp Detection System (APDS) Medical Device
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- De-Identified procedure report which was visually inspected to verify that it includes all the needed details about the polyps that were detected during the procedure.
研究概览
简要总结
The study shall mainly help to better evaluate the performance the APDS device and secondly it may help to assess the potential of the future alpha version of the device to be a useful and effective for the detection of colon Polyps.
详细描述
Primary objectives • To evaluate, in objective way, the usability of the future alpha version of the APDS device by testing the sensitivity and specificity of its results achieved from running it on the collected recorded videos of Colonoscopy screening tests of the general population.
Secondary objectives
• When the APDS would be ready for field installation (Beta Version), to install it in the Gastroenterology institute of the medical center, in order to evaluate, as part of a continuation study, the physicians satisfaction from the APDS performance.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must meet all the - criteria related to regular colonoscopy according to the standard of care at the Gastroenterology Department of the selected center, _In addition the following - criteria have to be met to be eligible for the study:
- •Able to read, understand and provide written Informed Consent;
- •Females or males - older than 18 years old
排除标准
- •Any of the following colonoscopy related exclusion criteria will exclude the subject from the study:
- •Bleeding disorder or unacceptable risk of bleeding
- •Terminal illness or life threatening malignancy
结局指标
主要结局
De-Identified procedure report which was visually inspected to verify that it includes all the needed details about the polyps that were detected during the procedure.
时间窗: Half an hour from the end of the procedure for which the procedure report was filled-in.
Each de-Identified procedure report is visually inspected immediately at the end of the procedure by an experienced team member who gives it binary score (0 or 1), 1 if it includes all the needed details about the polyps that were detected during the procedure, and 0 if does not include all the needed details about the polyps that were detected during the procedure. Only procedure reports which get the value of 1 can be used for full analysis of the recorded procedure.
Recorded colonoscopy video which was verified by visual inspection to have sufficient high quality.
时间窗: Half an hour from the end of the procedure at which the video was recorded.
Each recorded video is visually inspected immediately at the end of the procedure by an experienced team member who rates it with a number between 1 (the lowest quality) to 10 (the highest quality). This is a quality scale which indicates the general quality of the recorded video. Only videos with rate above 7 are considered as having sufficient high quality that enables to use them and analyze them.
次要结局
未报告次要终点