Evaluation of Feasibility and Accuracy of Assisted Fetal Heart Rate (FHR) Feature of the GE Vscan Access R2 Ultrasound System
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- GE Healthcare
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Difference in Fetal Heart Rate as Measured by VScan Access R2 and Corometrics
Study Overview
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.
Study Design
- Study Type
- Interventional
- Intervention Model
- Sequential
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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
Intervention: GE Corometrics 170 Series Fetal Monitor (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
Intervention: GE VScan Access R2 Ultrasound System (Device)
Outcomes
Primary Outcomes
Difference in Fetal Heart Rate as Measured by VScan Access R2 and Corometrics
Time Frame: 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 Outcomes
- 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))