Clinical Performance Evaluation of a Diagnostic Ultrasound System
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: Echocardiography. 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
- Китай
- 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
Clinical Performance Evaluation of the Vivid Pioneer Diagnostic Ultrasound System
Обзор
Subjects who are required to undergo transesophageal echocardiography according to the current clinical practice standards will be eligible for enrollment. Subjects will be screened for enrollment in this study against the inclusion and exclusion criteria. After successful screening and enrollment of subjects, the investigators will first use the investigational device to conduct transthoracic echocardiography (TTE), followed by transesophageal echocardiography (TEE). TEE will be conducted after the subject has been anesthetized. To avoid any delay in diagnosis and treatment, after the scan with the investigational device is completed, the probe will be reserved and the console will be switched to the existing commercial cardiac diagnostic ultrasound device in the study site for intraoperative guidance. In the study, each investigator will evaluate the overall image quality, user interface, workflow, user preferences, product preset, and functions of the system, as well as the device's safety and stability and fill out a user feedback questionnaire provided by the Sponsor.
Первичные конечные точки
- The main evaluation indicators include Overall system operation, Reliability, System operability, Overall image quality, etc., and the evaluation results are represented by five grades: Excellent, Very good, Good, Bad, and Very bad. [Срок оценки: From enrollment to Day 1 （Visit 1）]
Критерии участия
Критерии включения
- Adults ≥ 18 years old, have autonomous capacity;
- Subjects who are required to undergo intraoperative transesophageal echocardiography according to the current clinical practice standards;
- Agree to participate in this study and have signed the subject Informed Consent Form.
Критерии исключения
- Subjects who have been previously enrolled in this study or are participating in other clinical trials;
- Subjects with any medical emergency condition requiring urgent treatment;
- Pregnant females;
- Subjects with absolute contraindications of TEE (congenital or acquired upper digestive tract diseases, such as active upper gastrointestinal hemorrhage, esophageal obstruction or stenosis, esophageal tumor, esophageal lacerations and perforations, esophageal diverticula) or relative contraindications (changes in consciousness or lack of cooperation, history of cervical and mediastinal radiotherapy, history of recent esophageal surgery, esophageal varicosity, clotting disorders, cervical disease and injury, active esophagitis, active gastrointestinal ulcers, hiatal hernia, poor cardiopulmonary function, airway damage, pharyngeal space-occupying lesions, etc.), who are expected to be at high risks;
- Any other subjects who should not participate in this study in the investigator's opinion.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Другое
Центры проведения
Китай · 1 центр
- Nanjing First Hospital, Nanjing Medical University — Нанкин
Идентификаторы
NCT: NCT07066449 · KY20250225-05