Evaluation of Artificial Intelligence for Detection of Gastrointestinal Lesions in Endoscopy (EAGLE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 985
- 试验地点
- 15
- 主要终点
- Number of Adenoma per colonoscopy (APC)
研究概览
简要总结
The EAGLE study is a prospective randomized controlled multicenter parallel design trial, for the assessment of clinical performance of the CADDIE device and to confirm that the device performs as expected.
详细描述
The EAGLE study will be conducted with a parallel design. Patients who meet the study inclusion/exclusion criteria will be randomized in a 1:1 ratio to receive either computer-aided colonoscopy (CADDIE Arm) using CADDIE or standard colonoscopy without CADe (Control Arm). All resected polyps will be submitted for histologic examination.
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 (Outcomes Assessor)
盲法说明
Histology of the polyps is performed by the pathologist blinded to the study group assignment.
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
- •Screening or surveillance colonoscopy
- •Age 40 years or older
- •Informed consent
排除标准
- •Emergency colonoscopies
- •Inflammatory bowel disease (IBD)
- •Colorectal Cancer (CRC)
- •Previous Colorectal Cancer (CRC)
- •Previous colonic resection
- •Returning for a planned elective therapeutic colonoscopy.
- •Polyposis syndromes (familial adenomatous polyposis)
- •Contraindication for biopsy or polypectomy.
结局指标
主要结局
Number of Adenoma per colonoscopy (APC)
时间窗: During the procedure/surgery
Superiority of CADDIE Arm vs. control.
Positive percent agreement (PPA)
时间窗: During the procedure/surgery
Non inferiority of CADDIE Arm vs. control.
次要结局
未报告次要终点