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

• Registration Number: NCT03617419
• Lead Sponsor: GE Healthcare

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 Timeline

• Study Start: 2017-11-14
• Primary Completion: 2017-11-20
• Study Completion: 2018-02-26
• Study First Submitted: 2018-03-01
• Study First Submitted QC: 2018-08-03
• Study First Posted: 2018-08-06
• Results First Submitted: 2018-12-10
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-22
• Last Update Submitted: 2019-04-22
• Results First Posted: 2019-07-11
• Last Update Posted: 2019-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

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).

Trial Locations

Locations (1)

GE Healthcare - Milwaukee County Research Park; 🇺🇸 Wauwatosa, Wisconsin, United States