Artificial Intelligence Validation Trial for Polyp Detection: Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 357
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of the novel AI system compared to endoscopic diagnosis as gold standard
研究概览
简要总结
Interventional prospective multicenter study: Polyp detection by an automated endoscopic tool as second observer during routine diagnostic colonoscopy
详细描述
This is an investigator-initiated multicentre non-randomized prospective interventional trial to validate the performance of a novel state-of-the-art computer-aided diagnostic (CAD) tool in polyp detection implemented as second observer during routine diagnostic colonoscopy and to evaluate its feasibility in daily endoscopy. Patients referred for a screening surveillance or therapeutic colonoscopy will undergo a colonoscopy performed by an endoscopist with moderate to high adenoma detection rate (ADR > 20% and < 50%) while a second observer will follow the procedure on a bedside AI-tool to count the number of detections made by the AI system and categorize the results into positive or negative results as follows (1) true positive, (2) false negative, (3) other positive and (4) obvious false positive. When a doubtful detection is made by the AI-system, the second observer will ask to re-evaluate the indicated region. When the detection is clear, the endoscopist and second observer do not communicate. The entire procedure is recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •> 18 years
- •Diagnostic or screening colonoscopy
- •Therapeutic colonoscopy
排除标准
- •Inability to give informed consent by the patient or legal representative
- •< 18 years old
- •Any contraindication for colonoscopy or biopsies of the colon
- •Uncontrolled coagulopathy
- •Confirmed diagnosis of inflammatory bowel disease
- •Short bowel or ileostomy
- •Pregnancy
研究组 & 干预措施
Intervention arm
Colonoscopy with AI
干预措施: Artificial intelligence for polyp detection (Diagnostic Test)
结局指标
主要结局
Diagnostic accuracy of the novel AI system compared to endoscopic diagnosis as gold standard
时间窗: 4 months
Determination of the diagnostic accuracy of the novel AI system as second observer
次要结局
- Endoscopist's polyp miss rate as number of extra AI detections(4 months)
