Development Of Medical Ultrasound Systems, Accessories, And Components - GE Bangalore
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Completion of diagnostic ultrasound exam
研究概览
简要总结
Ultrasound devices components and accessories are under continuous development in order to optimize, validate and improve the devices, including improving the quality of images. In this study, GEHC proposes to collect data in order to achieve the following
- Aim 1: Perform iterative evaluations of the device (including features, accessories and components) to optimize device performance, assess feasibility of new features, and to perform testing necessary to support product and technology development;
- Aim 2: Perform activities to support design validation and/or to confirm user requirements and specifications have been met, as per design controls and other applicable requirements;
- Aim 3: Evaluate device complaints and analyze potential causes. There is no animal or phantom model that is adequate to accomplish these aims; therefore human subjects are required.
Due to the inherently varied nature of study data, specific data points will be recorded on a per-case basis and the study final report will summarize at minimum number and type of study scans conducted. Electronic image data may be collected. The number and type of safety issues, including adverse events (AEs) and serious adverse events (SAEs) will be reported. Unexpected device issues that occur outside of expected and controlled engineering optimization will be reported.
详细描述
Subjects will be considered enrolled that provide written informed consent to participate, and with thereafter be scheduled to attend up to up to five (5) ultrasound scans per day lasting up to 60 cumulative minutes each with approximately a 15 minute break before starting another study scan (limited to 15 cumulative minutes of scan time per eye, per day for ophthalmic scanning) as long as they remain eligible per the study inclusion and eligibility criteria. Vital sign information about subjects may be collected and subjects will be positioned for scanning of a variety of target anatomic areas using a variety of non-invasive, transcutaneous techniques, such as scanning abdominal, musculoskeletal, breast(s), peripleural, transcranial, cervical/neck, cardiac, ophthalmic, vascular, extremity, soft tissue, and other accessible anatomical regions. The subject will be monitored for adverse events throughout the research study scan. The resultant images and associated data will be recorded and stored as part of study data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Aged 18 years or older
- •Able and willing to provide written informed consent in accordance with the PNDT Act in India
- •Able to understand and respond in English
- •General Electric (GE) employee or contractor at the John F. Welch Technology Centre (JFWTC) facility.
排除标准
- •Direct employee or contractor of the General Electric (GE) Ultrasound business at the John F. Welch Technology Centre (JFWTC) facility
- •If female, pregnant or unsure of her pregnancy status per self-report.
- •Is not able to or would be put at additional risk from completing study activities, in the opinion of the study staff.
- •Subjects who have an electronic medical device at the time of the study scan (such as pacemaker, implantable cardioverter/defibrillator, insulin pump, cochlear implant, or other implanted electronic medical device).
结局指标
主要结局
Completion of diagnostic ultrasound exam
时间窗: 1 day
Parameters, features, and operator notes from the exam will be recorded to support diagnostic exam completion
次要结局
未报告次要终点