Computer Aided Detection, Tandem Colonoscopy Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Number of adenomas detected in combination technique compared to adenomas detected in standard technique Measured by Adenoma Miss Rate (AMR)
研究概览
简要总结
The purpose of this project is to examine the role of machine learning and computer aided diagnostics in automatic polyp detection and to determine in real-time how a computer-aided detection (CADe) algorithm will perform when compared to standard screening or surveillance colonoscopy alone. Design will be a multi-center, prospective, unblinded randomized tandem colonoscopy study. 196 patients referred for either screening or surveillance colonoscopy will be included.
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
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients presenting to the endoscopy unit for a screening colonoscopy or a surveillance colonoscopy
- •Willingness to undergo tandem colonscopies with and without the use of computer-aided software while undergoing conventional colonoscopy with sedation
- •Ability to provide written, informed consent (approved by IRB) and understand the responsibilities of trial participation
排除标准
- •People with diminished cognitive capacity
- •Patients undergoing diagnostic colonoscopy (e.g. as an evaluation for active GI bleed)
- •Patients with incomplete colonoscopies (those where endoscopists did not successfully intubate the cecum due to technical difficulties or poor bowel preparation)
- •Patients that have standard contraindications to colonoscopy in general (e.g. documented acute diverticulitis, fulminant colitis and known or suspected perforation).
- •Patients with inflammatory bowel disease
- •Patients referred for endoscopic mucosal resection (EMR)
结局指标
主要结局
Number of adenomas detected in combination technique compared to adenomas detected in standard technique Measured by Adenoma Miss Rate (AMR)
时间窗: 1 Year
AMR will be calculated as the number of adenomas detected on the second pass or portion in either group divided by the total number of adenomas detected during both passes.
次要结局
未报告次要终点