NCT05963724已完成不适用
Efficacy of Real-Time Computer Aided-Detected of Colonic Neoplasia in an Underserved Population, A Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,100
- 试验地点
- 1
- 主要终点
- Adenoma Detection Rate
研究概览
简要总结
This study assesses the sensitivity and added benefits of computer-aided detection compared to standard care (white-light) in detecting colon polyps in patients undergoing colonoscopy.
详细描述
Failure in polyp detection leads to colon cancer after colonoscopy. Artificial intelligence systems allow real-time computer-aided detection of polyps with high-accuracy. This study will compare GI-Genius, a real-time CAD system to standard colonoscopy in terms of how many colonoscopies detect an adenoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing colonoscopy at RUHS
- •Age > 45 years
- •No contraindications to colonoscopy
排除标准
- •Prior history of subtotal colectomy
研究组 & 干预措施
Standard Colonoscopy
Active Comparator
干预措施: Stanford Colonoscopy (Procedure)
Real-Time Computer Aided Detection
Experimental
干预措施: Real-Time Computer Aided Detection (Device)
结局指标
主要结局
Adenoma Detection Rate
时间窗: 1 year
次要结局
- False Neoplasia Rate(1 year)
- Adenomas Per Colon(1 year)
- Sessile Serrated Lesions Per Colon(1 year)
- Withdrawal Time(1 year)
- Sessile Serrated Lesion Detection Rate(1 year)
研究者
研究点 (1)
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