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临床试验/NCT04399590
NCT04399590已完成不适用

Comparing the Number of False Activations Between Two Artificial Intelligence CADe Systems: the NOISE Study

Istituto Clinico Humanitas1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年9月1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
40
试验地点
1
主要终点
To evaluate the cause of False Positives (FPs) signals, their frequenTocy and time rate, on two different CAD systems: CADe (GI Genius, Medtronic) and CADe/CADx (CAD EYE, Fujifilm) and report a comparison among the two

研究概览

简要总结

One fourth of colorectal neoplasias are missed during screening colonoscopies-these can develop into colorectal cancer (CRC). In the last couple of years, Artificial Intelligence Deep learning systems were introduced in the endoscopic setting to allow for real-time computer-aided detection/characterization (CAD) of polyps with high- accuracy. Few CADe (detection) and CADx (diagnosis, characterization) have been therefore proposed with this purpose. Because CAD systems are based on deep learning where the computer directly learns polyp recognition from supervised data without any human-control on the final algorithm, their outcome incorporates some unpredictability in the clinical setting that must be cautiously interpreted after its application. This means that the endoscopist may be presented with FP images that he would have never been selected in the first place as suspicion areas. These FPs may hamper the efficiency of CADe-colonoscopy. Additional time may be required to discriminate between an actual FP and a possible false negative result. An excess of FPs may reduce the motivation of the endoscopist for CADe, leading to its underuse in clinical practice. Although the indications of a CADe must always be interpreted by physician, FP may result in unnecessary polypectomy with related adverse events when used without appropriate training. Yet, there is a lack of information among quantity and quality of False Positive signals provided by the systems. From a post-hoc analysis of a Randomized Clinical Trial, in which we extracted and analysed a video library of CADe-colonoscopy (GI Genius) performed in our institution Humanitas Clinical and Research Hospital IRCCS we aimed that False positives by CADe are primarily due to artefacts from the bowel wall. Despite a high frequency, FPs from this CADe system resulted in a negligible 1% increase of the total withdrawal time as most of them were immediately discarded by the endoscopists.

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

入选标准

  • Age over 18 years
  • Ability to provide and to give informed consent
  • Boston Bowel Preparation Score > 6 (>2 each segment)

排除标准

  • Boston Bowel Preparation Score < 6 (<2 each segment)
  • Patients who had chronic inflammatory bowel diseases (such as Chron or Ulcerative Colitis)
  • Inability to obtain written informed consent
  • Patient unwilling to participate to the study

结局指标

主要结局

To evaluate the cause of False Positives (FPs) signals, their frequenTocy and time rate, on two different CAD systems: CADe (GI Genius, Medtronic) and CADe/CADx (CAD EYE, Fujifilm) and report a comparison among the two

时间窗: 6 Months

次要结局

未报告次要终点

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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