Clinical trial NCT03617419: Vscan Access R2 Feasibility Evaluation
Official title: Evaluation of Feasibility and Accuracy of Assisted Fetal Heart Rate (FHR) Feature of the GE Vscan Access R2 Ultrasound System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gather Feasibility Data and User Feedback on Use of a Device in Vivo on Pregnant Volunteers in Their 2nd and 3rd Trimester
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2018-08-06
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: SEQUENTIAL
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).
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Difference in Fetal Heart Rate as Measured by VScan Access R2 and Corometrics
timeFrame: 1 day - Up to 45 minutes of total scan time
Secondary outcomes:
measure: GE Voluson P8 Confirmation of Visualization of Fetal Heart With Yes/No Answer Per Subject
timeFrame: 1 day - Up to 45 minutes of total scan time (5 minutes for this specific measurement)
Other outcomes:
measure: Number of Adverse Events (AE/SAE) Reported During Study
timeFrame: Collected from the time subject signs informed consent form to the time of completion of subject's scan session, estimated up to 4 hours
measure: Number of Scan Operators Who Completed Surveys Regarding Usability of Vscan Access R2 Device
timeFrame: 10 minute survey completed by scan operators upon completion their participation (only one day per user)
measure: Number of Device Issues/Complaints Reported by Site
timeFrame: Three weeks (estimated study duration)
Locations:
city: Wauwatosa
country: United States
facility: GE Healthcare - Milwaukee County Research Park
state: Wisconsin
Study officials:
References: