跳至主要内容
临床试验/NCT06008847
NCT06008847已完成不适用

Capsule Endoscopy Delivery at sCale Through Enhanced AI anaLysis Study

University Hospitals Coventry and Warwickshire NHS Trust1 个研究点 分布在 1 个国家目标入组 720 人开始时间: 2022年2月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
720
试验地点
1
主要终点
Sensitivity and specificity of polyp detection in AI enabled CCE reporting

研究概览

简要总结

The CESCAIL study tests the use of Artificial Intelligence (AI) on a video taken from a minimally-invasive imaging device, to improve efficiency and accuracy of the detection of polyps, which are little outgrowths within the lining of the bowel.

详细描述

Participants will be continuing to follow their standard care pathway, and there are no additional requirements of the participants other than providing consent for their pseudonymised capsule video and data to be used to test the AI system.

The participant's final diagnosis will only be determined by the clinician's standard analysis pathway and not influenced by the AI enabled analysis pathway. All data is de-identified before a video is created and re-identified only once the standard final report is signed-off by the referring clinician. Therefore, the risk of patient harm due to exposed data is minimised.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

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

入选标准

  • Aged 18 or over
  • Patients who have been selected by overseeing clinician meeting NHS England criteria to undergo colon capsule endoscopy as part of their standard of care

排除标准

  • Patients unable to provide consent to take part in the study

研究组 & 干预措施

Lower Gastrointestinal Symptoms

Participant aged over 18 with referred lower gastrointestinal symptoms

结局指标

主要结局

Sensitivity and specificity of polyp detection in AI enabled CCE reporting

时间窗: 11 months

Sensitivity and specificity of polyp detection in AI enabled CCE reporting

Time taken to read video by clinicians and AI tool

时间窗: 11 months

Time taken to read video by clinicians and AI tool

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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