Gather Feasibility Data and User Feedback on Use of a Device in Vivo on Pregnant Volunteers in Their 2nd and 3rd Trimester
Conditions
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.
Interventions
DEVICEGE VScan Access R2 Ultrasound System
A diagnostic ultrasound imaging system manufactured by the study Sponsor.
DEVICEGE Corometrics 170 Series Fetal Monitor
A reference device to record a continuous fetal heart rate.
Sponsors
GE Healthcare
Study design
Intervention model
SEQUENTIAL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
This study is being done to evaluate and gather feasibility data and user feedback on the use of the Vscan Access R2 device in vivo on pregnant volunteers in their 2nd and 3rd Trimester. The study will be conducted in two parts, including an initial pilot for determination of parameters (Part 1) and continued testing (Part 2).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events (AE/SAE) Reported During Study | Collected from the time subject signs informed consent form to the time of completion of subject's scan session, estimated up to 4 hours | Summary of type and number of AEs, SAEs reported/recorded during course |
| Number of Scan Operators Who Completed Surveys Regarding Usability of Vscan Access R2 Device | 10 minute survey completed by scan operators upon completion their participation (only one day per user) | Series of nine questions regarding usability, ease of use, and workflow |
| Number of Device Issues/Complaints Reported by Site | Three weeks (estimated study duration) | Device Issues, Complaints, and Malfunctions will be reported in a table (type and number) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
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. | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | VScan Access R2 Ultrasound System |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 0 Participants |
| Trimester (2nd or 3rd) 2nd Trimester of Pregnancy | 8 Participants |
| Trimester (2nd or 3rd) 3rd Trimester of Pregnancy | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
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
Time frame: 1 day - Up to 45 minutes of total scan time
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VScan Access R2 Ultrasound System | Difference in Fetal Heart Rate as Measured by VScan Access R2 and Corometrics | 4.2 Beats Per Minute (BPM) | Standard Deviation 4.13 |
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).
Time frame: 1 day - Up to 45 minutes of total scan time (5 minutes for this specific measurement)
Population: Subjects in Part 1 (2) and Part 2 (14)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VScan Access R2 Ultrasound System | GE Voluson P8 Confirmation of Visualization of Fetal Heart With Yes/No Answer Per Subject | 16 Yes responses |
Other Pre-specified
Number of Adverse Events (AE/SAE) Reported During Study
Summary of type and number of AEs, SAEs reported/recorded during course
Time frame: Collected from the time subject signs informed consent form to the time of completion of subject's scan session, estimated up to 4 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VScan Access R2 Ultrasound System | Number of Adverse Events (AE/SAE) Reported During Study | 0 AEs / SAEs Reported |
Other Pre-specified
Number of Device Issues/Complaints Reported by Site
Device Issues, Complaints, and Malfunctions will be reported in a table (type and number)
Time frame: Three weeks (estimated study duration)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VScan Access R2 Ultrasound System | Number of Device Issues/Complaints Reported by Site | 0 Device Malfunctions |
Other Pre-specified
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
Time frame: 10 minute survey completed by scan operators upon completion their participation (only one day per user)
Population: Device Operators
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VScan Access R2 Ultrasound System | Number of Scan Operators Who Completed Surveys Regarding Usability of Vscan Access R2 Device | 9 Completed Usability Surveys |