Computer Aided Polyp Detection (C3PO) Trial: A Multicenter International Trial Evaluating Diagnostic Accuracy of Artificial Intelligence System in Detecting Colon Polyps
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 1,000
- 主要终点
- To investigate the accuracy of the novel Pentax Discovery CADe system (Discovery-AI) against pre-recorded videos of colon polyps of various size, shape and pathology while using videos of normal colon segments as controls
研究概览
简要总结
Computer aided detection (CADe) algorithms have been developed to overcome human errors and assist endoscopists in detecting more polyps during colonoscopy. The aim of this study was to investigate the accuracy of the novel Pentax Discovery CADe system (Discovery-AI) against pre-recorded videos of colon polyps of various size, shape and pathology while using videos of normal colon segments as controls from two different institutes.
详细描述
Details regarding polyp size and location, morphology including Paris classification, optical assessment, and bowel preparation were prospectively collected and recorded in the online Redcap software. Final results of polyp histology were also collected. The video library was then independently reviewed for quality assessment by 3 experienced gastroenterologists. Videos that passed the initial quality assessment were then independently evaluated using the Discovery-AI system.
Aim of the study was to evaluate overall performance of Discovery-AI system for polyps of various size, morphology and pathology utilizing a prospectively developed video library.
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
- 否
入选标准
- •Patients scheduled for a regular or screening colonoscopy at the institution as standard of care.
- •Over 18 years of age
排除标准
- •None if they qualify based on inclusion criteria
- •Pregnant patients
- •Inmate or prisoners
- •Unable to provide informed consent
结局指标
主要结局
To investigate the accuracy of the novel Pentax Discovery CADe system (Discovery-AI) against pre-recorded videos of colon polyps of various size, shape and pathology while using videos of normal colon segments as controls
时间窗: 3 years
The video library was developed during screening and surveillance colonoscopy and included details on polyp size, location, morphology, overall Boston bowel preparation score (BBPS) and segmental BBPS. Each video segments ranged from 35 seconds to 75 seconds. Before inclusion, each video was evaluated by 3 expert endoscopists individually to assess overall quality of the video. Quality of video was assessed based on pixel resolution and aspect ratio, bowel preparation, overall speed of withdrawal, colon distension, and adequate mucosal exposure. If the video was deemed of adequate quality by at least 2 endoscopists, it was included in the study cohort.
次要结局
未报告次要终点
研究者
Nirav C Thosani
Associate Professor
The University of Texas Health Science Center, Houston