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临床试验/NCT04378660
NCT04378660已完成不适用

Artificial Intelligence Validation Trial for Polyp Detection: Pilot Study

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 357 人开始时间: 2019年10月30日最近更新:
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
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

Experimental

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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