NCT06469671尚未招募不适用
Artificial Intelligence - Assisted Colonoscopy in Diagnosis of Colorectal Neoplasms: Russian Multicenter Randomised Open - Label Trial
State Scientific Centre of Coloproctology, Russian Federation2 个研究点 分布在 2 个国家目标入组 1,000 人开始时间: 2024年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 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
The primary goal of this study is to estimate the effectiveness of a medical decision support system based on artificial intelligence in the endoscopic diagnosis of benign tumors.
Researchers will compare Adenoma detection rate between "artificial intelligence - assisted colonoscopy" and "conventional colonoscopy" groups to evaluate the clinical effectiveness of artificial intelligence model.
详细描述
The primary outcome is adenoma detection rate per patient.
The secondary outcomes will be measured:
- Polyps detection rate (all type of lesions) per patient;
- Number of adenomas per patient;
- Number of polyps per patient;
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Screening coloscopy is needed
排除标准
- •Indications for colonoscopy
- •Previously detected colorectal neoplasms
- •Previously performed colorectal surgery
- •Colorectal cancer
- •Inflammatory bowel disease
结局指标
主要结局
Adenoma detection rate
时间窗: during the procedure
In each group, the percentage of patients with at least one histologically proven adenoma or carcinoma
次要结局
- Number of polyps(during the procedure)
- Polyps detection rate(during the procedure)
- Number of adenomas(during the procedure)
研究者
研究点 (2)
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