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临床试验/NCT05141409
NCT05141409已完成不适用

The COMBO CAD Study: Characterization cOMparison Between twO CAD Systems

Istituto Clinico Humanitas1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2022年1月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
500
试验地点
1
主要终点
AI-assisted optical diagnosis performance

研究概览

简要总结

Implementation of clinical strategies based on optical diagnosis of <5 mm colorectal polyps may lead to a substantial saving of economic and financial resources. Despite this, 84.2% of European endoscopists reported not to use such strategies - also named as leave-in situ and resect- and-discard - in their practice due to the fear of an incorrect optical diagnosis.

Indeed, accuracy of optical diagnosis is operator-dependent, and values reported in the community setting are below the safety thresholds proposed for its incorporation in clinical practice.

Artificial intelligence (AI) is being increasingly explored in different domains of medicine, particularly those entailing image analysis. As optical diagnosis involves subitaneous processing of multiple images, searching for specific visual clues, and recognizing well-defined visual patterns, AI systems has the potential to help endoscopists in distinguish neoplastic from non-neoplastic polyps, making the characterization process more reliable and objective. Computer-Aided-Diagnosis systems aiming at characterization are called CADx.

Preliminary data on CADx showed a high feasibility and accuracy of AI for optical diagnosis of colorectal polyp, and initial experiences in clinical practice confirmed preliminary results.

To assess the potential benefit and risk of AI-assisted optical diagnosis with standard colonoscopy, we exploited two new Computer-Aided-Diagnosis systems (CAD-EYE® Fujifilm Co., and GI-Genius® Medtronic) that provide the endoscopist with a real-time polyp characterization without the need of optical magnification.

研究设计

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

入排标准

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

入选标准

  • All patients aged 40 or older undergoing a colonoscopy for gastrointestinal symptoms, fecal immunohistochemical test positivity, primary screening or post-polypectomy surveillance

排除标准

  • subjects with personal history of CRC, or IBD.
  • Subjects affected with Lynch syndrome or Familiar Adenomatous Polyposis.
  • patients with inadequate bowel preparation (defined as Boston Bowel Preparation Scale < 2 in any colonic segment).
  • patients with previous colonic resection.
  • patients on antithrombotic therapy, precluding polyp resection.
  • patients who were not able or refused to give informed written consent.

结局指标

主要结局

AI-assisted optical diagnosis performance

时间窗: 6 Months

AI-assisted optical diagnosis performance

次要结局

  • AI alone optical diagnosis performance(6 Months)

研究者

发起方
Istituto Clinico Humanitas
申办方类型
Other
责任方
Sponsor

研究点 (1)

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