NCT05481632已完成不适用
Validating the Safety and Effectiveness of ENDOANGEL Lower Gastrointestinal Endoscope Image Auxiliary Diagnostic Software
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,360
- 试验地点
- 1
- 主要终点
- sensitivity of polyps identification
研究概览
简要总结
To evaluate the safety and effectiveness of ENDOANGEL Lower Gastrointestinal Endoscope Image Auxiliary Diagnostic Software developed and manufactured by Wuhan ENDOANGEL Medical Technology Co., Ltd.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years old ≤ age ≤ 75 years old, male or female;
- •Subjects with colonoscopy diagnosis and screening needs;
- •Sign the Written Informed Consent Form;
- •With full capacity for civil conduct.
排除标准
- •History of acute myocardial infarction (within 6 months), severe heart, liver, and renal insufficiency or mental disease;
- •Patients who are taking aspirin, warfarin, and other anticoagulants;
- •Patients with inflammatory bowel disease, or polyposis syndromes, or confirmed or highly suspected colon cancer;
- •History of colorectal surgery;
- •Patients with familial adenomatous polyposis;
- •Pregnant women (if the subject is a woman of reproductive age and cannot confirm whether she is pregnant, a pregnancy test is required);
- •Patients who are participating in clinical trials of other drugs or medical devices;
- •Patients who are not eligible to participate in this clinical trial in the opinion of the investigator.
结局指标
主要结局
sensitivity of polyps identification
时间窗: 3 months
The numerator is the number of true positives and the denominator is the total number of true positives and false negatives.
specificity of polyps identification
时间窗: 3 months
The numerator is the number of true negatives and the denominator is the total number of true negatives and false positives.
次要结局
- Polyp detection rate(3 months)
研究者
研究点 (1)
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