A Multi-center Control Study to Determine the Efficacy of CADEYE in Detecting Colon Polyps in Comparison to Standard of Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Adenoma detection rate
研究概览
简要总结
This study is to assess the sensitivity and added benefits of CADEYE compared to standard care (white-light) in detecting colon polyps in patients undergoing colonoscopy.
详细描述
Failure in polyp recognition is a major determinant for the high rate of missed colorectal neoplasms. In response, technological advances have paved the way for Computer-Aided Polyp Detection (CAD-e) systems. Artificial intelligence systems allow of real-time computer- aided detection of polyps with high-accuracy. CADEYE is a CAD-e system (FUJIFILM) that enables real-time video processing at the same rate as the standard procedure.
The data generated from this study will provide an estimate of the ADR throughout the Middle East as well as assess the accuracy of CADEYE in detecting adenomas in comparison to standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •40-80 years old subjects
- •Subjects undergoing colonoscopy for the following: o Primary CRC screening
- •Post-polypectomy surveillance
- •Work up following FIT positivity
- •Symptoms/signs suspicions of CRC
- •Subjects must be willing to give written informed consent for the trial
排除标准
- •Unable to consent
- •Contraindicated to undergo endoscopy
- •Hospitalized patient
- •Patients with the following conditions:
- •History of colon resection
- •History of CRC
- •Antithrombotic therapy precluding colon resection o Inflammatory Bowel Disease (IBD)
- •Familial Adenomatous Polyposis (FAP)
- •Pregnant or lactating
- •Poor bowel preparation: BBPS 0 or 1 in a segment
结局指标
主要结局
Adenoma detection rate
时间窗: 1 year
Adenoma detection rate is the primary end point which is the percentage of patients with at least 1 histologically proven adenoma or carcinoma.
次要结局
- Proximal Adenoma detection rate(1 year)
- Withdrawal time(1 year)
- Non-neoplastic detection rate(1 year)
- Adenomas detected per colonoscopy(1 year)
研究者
Mostafa Ibrahim
Mostafa Ibrahim
Theodor Bilharz Research Institute