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临床试验/NCT05322993
NCT05322993招募中不适用

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 4,500 人开始时间: 2021年11月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
4,500
试验地点
3
主要终点
PDR after the use of AI, is there a learning effect?

研究概览

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
None

入排标准

性别
All
接受健康志愿者
是

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

研究组 & 干预措施

With artificial intelligence (AI)

Active Comparator

Use of GI Genius artificial intelligence device during colonoscopy.

干预措施: GI Genius (Device)

Without artificial intelligence

Active Comparator

Use of standard colonoscopy equipment without GI Genius.

干预措施: Standard white light colonoscope (Device)

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)

研究者

发起方
Haraldsplass Deaconess Hospital
申办方类型
Other
责任方
Sponsor

研究点 (3)

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