Vscan Access R2 Feasibility Evaluation

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

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03617419
• Other study ID #: 110.05-2017-GES-0001
• Status: Completed
• Phase: N/A
• Start date: November 14, 2017
• Est. completion date: February 26, 2018

Study information

• Verified date: April 2019
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: February 26, 2018
• Est. primary completion date: November 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	GE Healthcare - Milwaukee County Research Park	Wauwatosa	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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)
Other	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)
Primary	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	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)