Gather Feasibility Data and User Feedback on Use of a Device in Vivo on Pregnant Volunteers in Their 2nd and 3rd Trimester Clinical Trial
Official title:
Evaluation of Feasibility and Accuracy of Assisted Fetal Heart Rate (FHR) Feature of the GE Vscan Access R2 Ultrasound System
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.
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.
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