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临床试验/NCT05870332
NCT05870332招募中不适用

Nationwide Study of Artificial Intelligence in Adenoma Detection for Colonoscopy

King's College Hospital NHS Trust1 个研究点 分布在 1 个国家目标入组 4,000 人开始时间: 2023年10月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
4,000
试验地点
1
主要终点
CADe-ADR in real world practice

研究概览

简要总结

The goal of this trial is to determine whether use of a Computer Assisted Detection (CADe) programme leads to an increase in ADR for either units or individual colonoscopists, independent of setting or expertise

详细描述

This is a case-control study comparing adenoma detection rate (ADR) in hospitals (and individual colonoscopists), before, during and after use with an artificial intelligence unit called GI Genius™ (GIG). GIG is a Computer-assisted detection (CADe) module that assists the human colonoscopist in real-time, by detecting and marking out polyps during colonoscopy. It has been shown to be effective in expert colonoscopists, but the effect in non-expert, general, colonoscopists is not known.

The investigator wish to deploy GIG into colonoscopy through the UK using a step-wedge design. Sites will be randomly allocated a start date for GIG deployment, collecting data for four months prior to this. In this way, all sites will have the active intervention and will provide their own case-control data. (4 months collection prior to activating GIG, 4 months with GIG, 4 months afterwards without GIG)

The study will concentrate on non-expert colonoscopists, to determine whether GIG can increase ADR. Patients will undergo the same colonoscopy that they would have had in any case, with no additional trial visits or interventions. There will be no alteration to the usual care pathway from the patient's perspective.

If the investigator can prove GIG increases ADR in this way, it will provide support to roll out this technology routinely to improve the quality of colonoscopy nationwide.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any patient aged 18-85 scheduled for colonoscopy by current NHSE / British Society of Gastroenterology criteria

排除标准

  • Colonoscopy being performed for polyp surveillance
  • Unable to provide informed, written consent

结局指标

主要结局

CADe-ADR in real world practice

时间窗: 24 months

The primary outcome measure will be adenoma detection rate. This will be studied across three phases: prior to use of CADe (baseline practice), while using CADe (study period) and finally after CADe (without the device in situ: "washout" phase).

次要结局

  • Procedure time(24 months)
  • APC(24 months)
  • Polyp characteristics(24 months)

研究者

发起方
King's College Hospital NHS Trust
申办方类型
Other
责任方
Sponsor

研究点 (1)

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