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临床试验/NCT05322993
NCT05322993
已完成
不适用

Improving Polyp Detection Rate by Artificial Intelligence in Colonoscopy

Haraldsplass Deaconess Hospital3 个研究点 分布在 1 个国家目标入组 5,034 人2021年11月19日
适应症Colonic Polyp

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Colonic Polyp
发起方
Haraldsplass Deaconess Hospital
入组人数
5034
试验地点
3
主要终点
PDR after the use of AI, is there a learning effect?
状态
已完成
最后更新
3个月前

概览

简要总结

The aim of this study is to investigate if the use of artificial intelligence (AI) in colonoscopy improves the polyp detection rate, and if the use of AI has a learning effect.

详细描述

The endoscopists will use GI Genius from Medtronic, a device that uses artificial intelligence (AI) based on machine learning to detect polyps in the colon in real time during colonoscopy. The device interprets the endoscopy pictures and superimposes possible polyps with frames. The patients will be included in regular outpatient clinics in Western Norway. The endoscopists will be divided into groups depending on their experience. The endoscopists will perform colonoscopies in three phases; (1) before the use of AI, (2) during the use of AI and (3) after the use of AI. The investigators will then evaluate the polyp detection rate (PDR) in the three phases to see if AI increases PDR, and if there is a learning effect on PDR after the use of AI. The investigators will also evaluate if there is a difference in the learning-effect from AI-use depending on if the endoscopist is experienced or inexperienced. The PDR's are registered as part of Norway's national quality register of colonoscopy, Gastronet. The data registered in Gastronet can also help the investigators evaluate other outcomes such as withdrawal time, bowel preparation, patient reported pain, patient satisfaction and complications.

注册库
clinicaltrials.gov
开始日期
2021年11月19日
结束日期
2025年6月30日
最后更新
3个月前
研究类型
Interventional
研究设计
Crossover
性别
All

研究者

发起方
Haraldsplass Deaconess Hospital
责任方
Sponsor

入排标准

入选标准

  • Patients coming to outpatient clinics to perform colonoscopies

排除标准

  • Total colectomy
  • Reservation against registration in Gastronet, the national quality register for colonoscopy in Norway

结局指标

主要结局

PDR after the use of AI, is there a learning effect?

时间窗: 18 months

Evaluate if there is an improved PDR after the use of AI

Polyp detection rate (PDR) with and without artificial intelligence (AI)

时间窗: 18 months

Evaluate the PDR with and without the use of GI Genus artificial intelligence

次要结局

  • Withdrawal time(18 months)
  • Complications(24 months)

研究点 (3)

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