Vscan Access R2 Feasibility Evaluation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Feasibility and Accuracy of Assisted Fetal Heart Rate (FHR) Feature of the GE Vscan Access R2 Ultrasound System

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

Intervention / Treatment
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* Device: GE VScan Access R2 Ultrasound System
* Device: GE Corometrics 170 Series Fetal Monitor
* Device: GE Corometrics 170 Series Fetal Monitor


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Sequential Assignment
Interventional Model Description: This study is being done to evaluate and gather feasibility data and user feedback on the use of the Vscan Access R2 device in vivo on pregnant volunteers in their 2nd and 3rd Trimester. The study will be conducted in two parts, including an initial pilot for determination of parameters (Part 1) and continued testing (Part 2).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: VScan Access R2 Ultrasound System<br>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 | Device: GE VScan Access R2 Ultrasound System<br>* A diagnostic ultrasound imaging system manufactured by the study Sponsor.<br>Device: GE Corometrics 170 Series Fetal Monitor<br>* A reference device to record a continuous fetal heart rate.<br>Device: GE Corometrics 170 Series Fetal Monitor<br>* A reference device for verification of scanning the fetal heart.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Fetal Heart Rate as Measured by VScan Access R2 and Corometrics | Absolute difference and variance in fetal heart rate (in BPM) measured using VScan Access R2 and Corometrics | 1 day - Up to 45 minutes of total scan time | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GE Voluson P8 Confirmation of Visualization of Fetal Heart With Yes/No Answer Per Subject | 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). | 1 day - Up to 45 minutes of total scan time (5 minutes for this specific measurement) |