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Набор скоро начнётся NCT06543862

Autonomous Artificial Intelligence Versus AI Assisted Human Optical Diagnosis

Без фазы С лечением Colonic Polyp Artificial Intelligence

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: CADx (AI) system.
Кому может быть актуально
Состояния в реестре: Colonic Polyp, Artificial Intelligence. Базовые параметры: 45 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
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Официальное название

Autonomous Artificial Intelligence Versus AI Assisted Human Optical Diagnosis of Colorectal Polyps

Обзор

Computer-aided image-enhanced endoscopy can predict the nature of colorectal polyps with over 90% accuracy. This technology uses artificial intelligence (AI) to analyze video recordings of polyps, learning to make diagnoses in real-time. This means that doctors can get immediate predictions about small polyps during the procedure, reducing the need for separate pathology exams and saving costs, ultimately improving patient care. Human and AI interactions are complex and a framework to reap synergistic effects CADx systems when used by humans to harness optimal performance needs to be established. AI solutions in medicine are usually developed to be used as assistive devices, however, then they rely on humans to correct AI errors. Optical polyp diagnosis is a complex task. Non experts usually achieve diagnostic accuracy in 70-80%. CADx systems have a similar diagnostic accuracy when used autonomously. Clinical evaluation of CADx systems showed that CADx assisted OD performs equally to the operator performance when using non CADx assisted OD. To harness a benefit of clinical CADx implementation we would have to find a way that synergies between human and CADx come into play to eliminate cases in which CADx assisted and/ or human OD results in low diagnostic accuracy and also addresses the problem of serrated polyp recognition.

Подробное описание

Our study hypothesis is that for CADx implementation, instead of using the high/low confidence framework, identifying cases with suboptimal diagnostic accuracy could be facilitated through identifying cases in which CADx and endoscopist disagreed in their diagnosis. Eliminating such cases might separate out cases with low accuracy when using CADx assisted OD. Since endoscopists have a high sensitivity but low specificity for serrated polyp OD, this framework will also allow us to implement a strategy to adequately manage serrated polyps found in the cohort.

Вмешательства

  • Другое CADx (AI) system
    The CADx system will be used to predict the histopathology of the polyp detected.

Первичные конечные точки

  • Accuracy of optical diagnosis, for polyps 1-5mm, compared with an agreed upon CADx-assisted diagnosis [Срок оценки: up to 100 weeks]
Вторичные конечные точки (6)
  • Accuracy of optical diagnosis, for polyps 1-10mm, compared with an agreed upon CADx-assisted diagnosis [Срок оценки: up to 100 weeks]
  • Test characteristics, including recall, specificity, positive and negative predictive values (PPV/NPV), and particularly the NPV of rectosigmoid neoplastic polyps. [Срок оценки: up to 100 weeks]
  • Agreement of surveillance interval recommendations of AI-A and AI-H compared with the pathology-based recommendations [Срок оценки: up to 100 weeks]
  • Proportion of patients for whom an immediate surveillance recommendation can be directly provided for each approach, and how often histopathology-based polyp examination would have been avoided. [Срок оценки: up to 100 weeks]
  • Variability of OD (AI-A and AI-H) across participating endoscopists. [Срок оценки: up to 100 weeks]
  • Cost-effectiveness of OD ((AI-A and AI-H) [Срок оценки: up to 100 weeks]

Критерии участия

Критерии включения

  • Indication for full colonoscopy.

Критерии исключения

  • Known inflammatory bowel disease
  • Active colitis
  • coagulopathy
  • familial polyposis syndrome
  • poor general health, defined as an American Society of Anesthesiologists class >3
  • emergency colonoscopy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

Канада · 1 центр
  • Ghislaine Ahoua — Montreal

Идентификаторы

NCT: NCT06543862 · 2025-12306

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗