Evaluation of Feasibility and Accuracy of Assisted Fetal Heart Rate (FHR) Feature of the GE Vscan Access R2 Ultrasound System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Difference in Fetal Heart Rate as Measured by VScan Access R2 and Corometrics
研究概览
简要总结
This study is being done to evaluate if the Vscan Access R2 Ultrasound System can measure Fetal Heart Rate (FHR) in humans when compared against a reference device (GE Corometrics 170 Series Fetal Monitor), and to gather feedback from device operators on the usability of the device.
详细描述
This study is being done to evaluate whether the Vscan Access R2 Ultrasound System Assisted FHR phantom testing conclusions can be extrapolated onto human fetal heart rate measurements, where CTG (GE Corometrics 170 Series Fetal Monitor) is to provide a reference value. It should be noted that the Vscan Access R2 Ultrasound System with Assisted FHR has a different intended use than CTG (momentary FHR value versus continuous monitoring of FHR patterns and trends) and this aspect is out of scope of this research.
Usability data will be gathered for further user experience optimization.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 18 years or older at the time of consent;
- •By self-report, are in the 2nd or 3rd trimester of pregnancy;
- •Able and willing to provide written informed consent for participation;
- •Provide a completed Healthcare Verification Form which confirms the subject has received at least one diagnostic ultrasound during this pregnancy and has an uncomplicated pregnancy.
排除标准
- •Are direct employees/contractors of General Electric (GE);
- •Are potentially put at additional risk by participating, in the opinion of study staff;
- •Twin pregnancies identified in patient medical history.
研究组 & 干预措施
VScan Access R2 Ultrasound System
Pre-market: Vscan Access R2 Ultrasound System
The following post-market products will be used on label:
GE Corometrics 170 Series Fetal Monitor - as a reference for value of fetal heart rate GE Voluson P8 Ultrasound System - for verification of fetal location during measurement
干预措施: GE VScan Access R2 Ultrasound System (Device)
VScan Access R2 Ultrasound System
Pre-market: Vscan Access R2 Ultrasound System
The following post-market products will be used on label:
GE Corometrics 170 Series Fetal Monitor - as a reference for value of fetal heart rate GE Voluson P8 Ultrasound System - for verification of fetal location during measurement
干预措施: GE Corometrics 170 Series Fetal Monitor (Device)
结局指标
主要结局
Difference in Fetal Heart Rate as Measured by VScan Access R2 and Corometrics
时间窗: 1 day - Up to 45 minutes of total scan time
Absolute difference and variance in fetal heart rate (in BPM) measured using VScan Access R2 and Corometrics
次要结局
- GE Voluson P8 Confirmation of Visualization of Fetal Heart With Yes/No Answer Per Subject(1 day - Up to 45 minutes of total scan time (5 minutes for this specific measurement))