Clinical Performance Evaluation of the Vivid Pioneer Diagnostic Ultrasound System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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.
时间窗: From enrollment to Day 1 （Visit 1）
次要结局
未报告次要终点
研究者
Juan Zhang
Deputy Chief Physician
Nanjing First Hospital, Nanjing Medical University