Pilot Study for the Assessment of the Quality of Echocardiography Exam When Obtained by Novice Users While Using the USEG Software.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- To assess the quality of clips obtained by novice users when using the USEG software.
研究概览
简要总结
The product is comprised of software that aids in automated guided ultrasound image acquisition for novice users (medical professional without experience in performing echocardiography, e.g. nurses, physicians assistants, medical doctors, medical student etc.).
The software provides real-time feedback during image acquisition to optimize image capture and determine whether image quality is sufficient for medical evaluation. The software is designed to be used with any echocardiographic ultrasound system. The Philips Lumify hand-held ultrasound device will be used for this study.
- Images can be acquired manually by a novice user.
- Each novice user will have a training course of 8 hours, before the study commences.
详细描述
Study Design:
This pilot study is a single center, multi-reader multi-case study, primarily designed to obtain the quality of the echocardiography exam, obtained by novice users when using the USEG software.
Eligible subject will undergo the examination twice on a single study visit : once by one of novice users when using the USEG software and once by one of the expert sonographers without the aid of the software.
Each novice user will perform the examination on approximately 30 subjects (depending on the number of novice user, with the aim that the number of examinations by each novice will be the same).
The assignment of the novice user and expert sonographer to subjects and their order within a subject will be based upon their availability once the subject's is enrolled. In case of more than 1 available novice, the exam will be assigned to the novice with the least exams performed so far.
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
- 是
入选标准
- •Age 18 and older
- •Subjects willing and able to give written informed consent.
排除标准
- •Emergency (non-elective) admission within 24 h prior to participating in the study
- •Female subjects who are pregnant (WOCBP* will perform a urine pregnancy test)
- •Unable to lie as required in all the classic positions for standard TTE exam: supine on back / left decubitus.
- •Subjects who currently participate a clinical trial, involving interventional cardiac devices
- •Subjects who have prior Echo exam with description of Low/Poor quality exam in the echo report
- •Subjects with BMI above 40
- •Subjects experiencing a known or suspected acute cardiac event
- •Subjects with severe chest wall deformity as per previous medical records and physical examination
- •Subjects who have undergone pneumonectomy
- •Subjects whose anatomy does not lend itself to yield diagnosable echocardiography clips (i.e. situs inversus with dextrocardia, single ventricle anatomy due to congenital heart defect, etc.)
- •A woman is of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis.)
结局指标
主要结局
To assess the quality of clips obtained by novice users when using the USEG software.
时间窗: 1 year.
The expert cardiologists will evaluate whether the echo examination has sufficient to evaluate each of the primary endpoints: 1. Sufficient quality to assess Left Ventricular (LV) size: (YES/NO) 2. Sufficient quality to assess LV function: (Yes/No) 3. Sufficient quality to assess Right Ventricular size: (Yes/No) 4. Sufficient quality to assess presence of non-trivial pericardial effusion: (Yes/No)
次要结局
- Sufficient quality assessment for six (6) anatomic elements.(1 year.)
- Diagnostic quality assessment.(1 year.)