Vscan Access R2 Feasibility Evaluation

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

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.

Study Overview

• Status: Completed
• Conditions: Gather Feasibility Data and User Feedback on Use of a Device in Vivo on Pregnant Volunteers in Their 2nd and 3rd Trimester
• Intervention / Treatment: Device: GE VScan Access R2 Ultrasound System; Device: GE Corometrics 170 Series Fetal Monitor; Device: GE Corometrics 170 Series Fetal Monitor

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Wauwatosa, Wisconsin, United States, 53226-4856
      • GE Healthcare - Milwaukee County Research Park

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Adverse Events (AE/SAE) Reported During Study	Summary of type and number of AEs, SAEs reported/recorded during course	Collected from the time subject signs informed consent form to the time of completion of subject's scan session, estimated up to 4 hours
Number of Scan Operators Who Completed Surveys Regarding Usability of Vscan Access R2 Device	Series of nine questions regarding usability, ease of use, and workflow	10 minute survey completed by scan operators upon completion their participation (only one day per user)
Number of Device Issues/Complaints Reported by Site	Device Issues, Complaints, and Malfunctions will be reported in a table (type and number)	Three weeks (estimated study duration)

Collaborators and Investigators

• Sponsor: GE Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2017
• Primary Completion (Actual): November 20, 2017
• Study Completion (Actual): February 26, 2018

Study Registration Dates

• First Submitted: March 1, 2018
• First Submitted That Met QC Criteria: August 3, 2018
• First Posted (Actual): August 6, 2018

Study Record Updates

• Last Update Posted (Actual): July 11, 2019
• Last Update Submitted That Met QC Criteria: April 22, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 110.05-2017-GES-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No