Development of New Diagnostic Tools in Capsule Endoscopy
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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Bowel Disease, Crohn Disease, Celiac Disease, Chronic Diarrhea. Базовые параметры: Без ограничений · 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
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
Patients participating to this study will provide images and videos of capsule endoscopy to train, tune and evaluate technological bricks of artificial intelligence solutions, in order to improve diagnostic performances of the procedure, while reducing reading time by physicians.
Подробное описание
Capsule endoscopy is a minimally-invasive diagnostic procedure based on the ingestion (or endoscopic delivery) of a miniaturized biocompatible, camera. Capsules capture tenths of thousands images of the digestive tract. Reading the captured images and reporting is long, tedious, and at risk of errors when the reader's attention is disturbed. Artificial intelligence is expected to alleviate these limitations, by both improving diagnostic performances of capsule endoscopy while reducing reading time.
Any patient in whom a capsule endoscopy examination is performed as part of routine care will be invited to participate to the study. Their de-identified images and videos will be extracted, thus allowing the creation of several databases for training, tuning and testing technological bricks of artificial intelligence. Basic clinical data will be collected (age, gender, indication for capsule endoscopy, type of device, ingestion or delivery of capsule). Images and videos will be characterized centrally and consensually by a panel of 3 expert readers, according to their level of relevance in relation to the type and indication of capsule endoscopy.
The various, developed technological bricks will aim to automatically detect and characterize anatomical landmarks and abnormal findings, and to quote the intestine cleanliness.
Assessment of diagnostic performance and reading time will be performed within a few months or up to five years, for each technological brick, individually and then combined, according to their stepwise development.
Первичные конечные точки
- Develop an artificial intelligence solution to help with diagnosis in VCE [Срок оценки: Through study completion, 5 years]
Вторичные конечные точки (4)
- Evaluation of the diagnostic performance of the A.I. solution in terms of detection [Срок оценки: Through study completion, 5 years]
- Evaluation of the diagnostic performance of the A.I. solution in terms of characterisation [Срок оценки: Through study completion, 5 years]
- Evaluation of the diagnostic performance of the A.I. solution in terms of recognition of anatomical landmarks [Срок оценки: Through study completion, 5 years]
- Evaluation of the diagnostic performance of the A.I. solution in terms of quality of preparation of the various segments of the digestive tract [Срок оценки: Through study completion, 5 years]
Критерии участия
Критерии включения
\- Any patient in whom a capsule endoscopy examination is performed as part of routine care.
Критерии исключения
\- Opposition to the use of images and videos from daily, routine care for research purposes.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Франция · 1 центр
- Centre d'Endoscopie Digestive Hôpital Saint-Antoine — Paris
Идентификаторы
NCT: NCT06152289 · APHP210791