NCT05687318已完成不适用
A Clinical Trial of the Effectiveness and Safety of Software Assisting Diagnose the Intestinal Polyp Digestive Endoscopy by Analysis of Colonoscopy Medical Images From Electronic Digestive Endoscopy Equipment, a Prospective, Multicenter, Randomized Stratified Block, Incomplete Blind Setting, Parallel Sequential Control, and Efficacy Test
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 337
- 试验地点
- 1
- 主要终点
- PMR
研究概览
简要总结
A clinical trial of the effectiveness and safety of intestinal polyp digestive endoscopy-assisted diagnosis software used in the analysis of colonoscopy medical images generated by electronic digestive endoscopy equipment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age of 18 to 85 years old, regardless of gender;
- •electronic colonoscopy is required;
- •The subjects or their legal representatives could understand the purpose of the trial, show sufficient compliance with the trial protocol, and sign the informed consent.
排除标准
- •(1) Contraindications associated with electronic colonoscopy or biopsy;
- •(2) poor intestinal preparation;
- •(3) diagnosed colorectal cancer, familial polyposis, or complicated with known colorectal polyps;
- •(4) serious neurological diseases or dysfunction of vital organs (heart, lung, liver, kidney);
- •(5) acute abdominal or intestinal inflammation;
- •(6) History of abdominal, pelvic, anal and perianal operations within 2 months before enrollment;
- •(7) Participated in other interventional clinical trials within 1 month before enrollment;
- •(8) In the interest of subjects, the investigator considers that they should not participate in other conditions of the clinical trial.
结局指标
主要结局
PMR
时间窗: during colonoscopy procedure
Polyp miss rate
次要结局
- AMR(during colonoscopy procedure)
研究者
研究点 (1)
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