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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VScan Access R2 Ultrasound System | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GE VScan Access R2 Ultrasound System | Device | A diagnostic ultrasound imaging system manufactured by the study Sponsor. |
|
| 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 |
| 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). |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Study of pregnant volunteers
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GE Healthcare - Milwaukee County Research Park | Wauwatosa | Wisconsin | 53226-4856 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1 |
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| Part 2 |
|
Data and results collected/analyzed for participants in active study phase (2). Pilot participant data not collected per study Protocol.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | Beats Per Minute (BPM) | 1 day - Up to 45 minutes of total scan time |
|
Adverse event collection period for duration of study scanning (~ one week).
Subject were monitored for AEs, SAEs, and UADEs during their study exams, until they exited the exam area. Procedures were conducted during a single visit (about one hour for each subject).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Clinical Affairs Project Manager | GE Healthcare | 2624095722 | kevin.r.siewert@ge.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 26, 2017 | Dec 7, 2018 | Prot_SAP_000.pdf |
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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).
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| GE Corometrics 170 Series Fetal Monitor | Device | A reference device to record a continuous fetal heart rate. |
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| GE Corometrics 170 Series Fetal Monitor | Device | A reference device for verification of scanning the fetal heart. |
|
| 1 day - Up to 45 minutes of total scan time (5 minutes for this specific measurement) |
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) |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Trimester (2nd or 3rd) | Count of Participants | Participants |
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| 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). | Subjects in Part 1 (2) and Part 2 (14) | Posted | Number | "Yes" responses | 1 day - Up to 45 minutes of total scan time (5 minutes for this specific measurement) |
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| Other Pre-specified | Number of Adverse Events (AE/SAE) Reported During Study | Summary of type and number of AEs, SAEs reported/recorded during course | Posted | Number | AEs / SAEs Reported | Collected from the time subject signs informed consent form to the time of completion of subject's scan session, estimated up to 4 hours |
|
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| 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 | Device Operators | Posted | Number | Completed Usability Surveys | 10 minute survey completed by scan operators upon completion their participation (only one day per user) |
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| 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) | Posted | Number | Device Malfunctions | Three weeks (estimated study duration) |
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| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
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