Vscan Access R2 Feasibility Evaluation

GE Healthcare16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

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

Interventions

GE VScan Access R2 Ultrasound SystemDEVICE

A diagnostic ultrasound imaging system manufactured by the study Sponsor.

GE Corometrics 170 Series Fetal MonitorDEVICE

A reference device to record a continuous fetal heart rate.

GE Corometrics 170 Series Fetal MonitorDEVICE

A reference device for verification of scanning the fetal heart.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Women aged 18 years or older at the time of consent; 2. By self-report, are in the 2nd or 3rd trimester of pregnancy; 3. Able and willing to provide written informed consent for participation; 4. 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: 1. Are direct employees/contractors of General Electric (GE); 2. Are potentially put at additional risk by participating, in the opinion of study staff; 3. Twin pregnancies identified in patient medical history.

Locations (1)

GE Healthcare - Milwaukee County Research Park

Wauwatosa, Wisconsin, United States

Outcomes

Primary Outcomes

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

Time frame: 1 day - Up to 45 minutes of total scan time

Secondary Outcomes

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).

Time frame: 1 day - Up to 45 minutes of total scan time (5 minutes for this specific measurement)

Data from ClinicalTrials.gov

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