Randomized, Controlled Trial of a Computer Aided Detection Device in Standard Colonoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,472
- 试验地点
- 5
- 主要终点
- Adenomas per colonoscopy
研究概览
简要总结
The aim of this study is to evaluate the clinical benefit and safety of using a computer aided detection device, Skout, for real-time polyp detection in colonoscopy procedures with the indication of screening or surveillance. One of the reasons for the development of interval colorectal cancers is polyps missed during colonoscopy. Our hypothesis is that with the aid of Skout, the adenomas detected per colonoscopy will increase, and it is plausible to believe that this increase in detection could reduce the incidence of interval cancers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants will be eligible for this study if they are:
- •Undergoing colonoscopy with screening, surveillance, or diagnostic indications.
- •Undergoing a procedure by a participating endoscopist.
- •Have given informed consent.
排除标准
- •Participants will not be eligible for this study if they:
- •Have a history of inflammatory bowel disease.
- •Have a history of familial adenomatous polyposis.
- •Are under the age of
- •Have had a colonoscopy within the previous three (3) years.
- •Undergoing diagnostic colonoscopy with high-risk indications including iron deficiency anemia, abnormal CT imaging, unexplained weight loss, Lynch Syndrome, blood in stool or FIT positive test.
- •Entered with poor bowel preparation (inadequate for procedure as assessed by the Investigator).
- •Use anti-platelet agents or anticoagulants that preclude the removal of polyps during the procedure.
研究组 & 干预措施
Control
Routine Colonoscopy
Experimental
Routine Colonoscopy with the use of Skout
干预措施: Computer Aided Detection device (Device)
结局指标
主要结局
Adenomas per colonoscopy
时间窗: At the end of the procedure, 1 day
The total number of adenomas detected divided by the total number of colonoscopies.
Positive predictive value
时间窗: At the end of the procedure, 1 day
The total number of adenomas and serrated lesions detected divided by the total number of extractions.
次要结局
- Adenoma detection rate(At the end of the procedure, 1 day)
- Colorectal cancer surveillance interval(At the end of the procedure, 1 day)
- Sessile serrated lesions detected(At the end of the procedure, 1 day)