Vscan Access R2 Feasibility Evaluation

Not Applicable

Completed

Conditions: Gather Feasibility Data and User Feedback on Use of a Device in Vivo on Pregnant Volunteers in Their 2nd and 3rd Trimester

Interventions: Device: GE VScan Access R2 Ultrasound System
Device: GE Corometrics 170 Series Fetal Monitor

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
VScan Access R2 Ultrasound System	GE Corometrics 170 Series Fetal Monitor	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
VScan Access R2 Ultrasound System	GE 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

Primary Outcome Measures

Name	Time	Method
Difference in Fetal Heart Rate as Measured by VScan Access R2 and Corometrics	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

Secondary Outcome Measures

Name	Time	Method
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)	Visualization of fetal heart as acquired from the GE Voluson P8 to verify that the fetal heart was correctly identified during the image acquisition using Vscan Access R2. This is gathered through a Yes/No confirmation by device operator as to whether it was the fetal heart being scanned (once for each subject).