Collecting Recorded Videos of Colonoscopy
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: Collecting recorded videos of Colonoscopy screening tests.
- Кому может быть актуально
- Состояния в реестре: Colon Polyp. Базовые параметры: от 18 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
- Израиль
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Collecting Recorded Videos of Colonoscopy Screening Tests for the Evaluation of the Automatic Polyp Detection System (APDS) Medical Device
Обзор
The study shall mainly help to better evaluate the performance the APDS device and secondly it may help to assess the potential of the future alpha version of the device to be a useful and effective for the detection of colon Polyps.
Подробное описание
Primary objectives • To evaluate, in objective way, the usability of the future alpha version of the APDS device by testing the sensitivity and specificity of its results achieved from running it on the collected recorded videos of Colonoscopy screening tests of the general population.
Secondary objectives
• When the APDS would be ready for field installation (Beta Version), to install it in the Gastroenterology institute of the medical center, in order to evaluate, as part of a continuation study, the physicians satisfaction from the APDS performance.
Вмешательства
- Другое Collecting recorded videos of Colonoscopy screening tests
To evaluate, in objective way, the usability of the future alpha version of the APDS device by testing the sensitivity and specificity of its results achieved from running it on the collected recorded videos of Colonoscopy screening tests of the general population.
Первичные конечные точки
- Recorded colonoscopy video which was verified by visual inspection to have sufficient high quality. [Срок оценки: Half an hour from the end of the procedure at which the video was recorded.]
- De-Identified procedure report which was visually inspected to verify that it includes all the needed details about the polyps that were detected during the procedure. [Срок оценки: Half an hour from the end of the procedure for which the procedure report was filled-in.]
Критерии участия
Критерии включения
Subjects must meet all the - criteria related to regular colonoscopy according to the standard of care at the Gastroenterology Department of the selected center, \_In addition the following - criteria have to be met to be eligible for the study:
- Able to read, understand and provide written Informed Consent;
- Females or males - older than 18 years old
Критерии исключения
Any of the following colonoscopy related exclusion criteria will exclude the subject from the study:
- Bleeding disorder or unacceptable risk of bleeding
- Terminal illness or life threatening malignancy
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Израиль · 1 центр
- Hadassah Medical Organization — Jerusalem
Идентификаторы
NCT: NCT03891251 · 0493-18-HMO