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临床试验/NCT06094270
NCT06094270已完成不适用

Artificial-intelligence-based Reporting Technology for Endoscopy Monitoring and Imaging System

Wuerzburg University Hospital1 个研究点 分布在 1 个国家目标入组 147 人开始时间: 2023年12月19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
147
试验地点
1
主要终点
Withdrawal time error comparison for colonoscopies using the proposed AI system versus physician estimation

研究概览

简要总结

Properly documenting withdrawal time in colonoscopy is essential for quality assessment and cost allocation. However, reporting withdrawal time has significant interobserver variability. Additionally, current manual documentation of endoscopic findings is time-consuming and distracting for the physician. This trial examines an artificial intelligence based system to determine withdrawal time and create a structured report, including high-quality images (AI) of detected polyps and landmarks.

详细描述

This study aims to compare withdrawal time precision calculated by an AI system with examiner-reported times during colonoscopy, also evaluating endoscopists' satisfaction with the images included in the AI-generated reports. The study will be single-center and endoscopist-blinded, where 138 patients are expected to be recruited, taking polyp detection rates and potential dropouts into consideration. Manual annotation of withdrawal times from examination recordings will establish gold standard annotations. The AI system performs a frame-by-frame analysis of endoscopy recordings, predicting endoscopic findings. Using a rule-based logic, the method calculates withdrawal time for the examination and automatically generates a report for the examination. The study will include consenting adult patients eligible for colonoscopy, excluding those meeting specific criteria.

In this observational study, the withdrawal time for the examinations of all recruited patients is estimated by both the physician and the AI method. The study does not relate to any particular indication, and any patient that is appointed for a colonoscopy and does not meet the exclusion criteria can be recruited. The AI method operates in the background, having no influence on the examination's process, or outcome. The standard procedure requires physicians to estimate the withdrawal time and document it in the examination report. Simultaneously, the proposed AI method also computes the withdrawal time for all patients in the background, without affecting the physician, the examination, or the outcomes of the examination. Importantly, the physician remains blinded to the AI model's output.

To establish the gold standard withdrawal time, manual calculations will be performed using the recorded examination data for all patients. This gold standard is used for evaluating errors in withdrawal time estimation made by both the physician and the AI method. Subsequently, a comparative analysis is conducted to assess the disparities between the physician's estimations and those of the AI method.

Furthermore, the AI method captures characteristic images of anatomical landmarks and notable events, such as polyp resections, during the examination. A panel of certified endoscopists will rigorously evaluate the quality and relevance of these selected images.

研究设计

研究类型
Observational
观察模型
Case Only
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
是

入选标准

  • •Adult patients (>18 years)
  • •Scheduled for colonoscopy

排除标准

  • •Patient / Examination level
  • •Inflammatory Bowel Disease
  • •Familial Polyposis Syndrome
  • •Patient after radiation/resection of colonic parts
  • •Endoscopic recordings started after beginning of withdrawal.
  • •Examination recordings stopped before the end of the examination.
  • •Examinations with corrupt video signal

结局指标

主要结局

Withdrawal time error comparison for colonoscopies using the proposed AI system versus physician estimation

时间窗: Through study completion, an average of 5 months

The error between gold standard withdrawal time and the withdrawal time estimated from the proposed AI system and the physician are compared for the same examination.

次要结局

  • Number of examination where withdrawal time could not be determined(Through study completion, an average of 5 months)
  • Image quality satisfaction(Through study completion, an average of 5 months)
  • Subgroup analysis for withdrawal time calculation error based on the presence or absence of resections in the examination.(Through study completion, an average of 5 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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