N/A
N=2
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
Bottom Line
View on ClinicalTrials.gov: NCT03617419 ↗Enrolled (actual)
2
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Difference in Fetal Heart Rate as Measured by VScan Access R2 and Corometrics — 4.2 Beats Per Minute (BPM)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- GE VScan Access R2 Ultrasound System (Device); GE Corometrics 170 Series Fetal Monitor (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- GE Healthcare
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Fetal Heart Rate as Measured by VScan Access R2 and Corometrics |
4.2 | — |
| SECONDARY GE Voluson P8 Confirmation of Visualization of Fetal Heart With Yes/No Answer Per Subject |
16 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Women aged 18 years or older at the time of consent;
- By self-report, are in the 2nd or 3rd trimester of pregnancy;
- Able and willing to provide written informed consent for participation;
- 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
- Are direct employees/contractors of General Electric (GE);
- Are potentially put at additional risk by participating, in the opinion of study staff;
- Twin pregnancies identified in patient medical history.
Data sourced from ClinicalTrials.gov (NCT03617419). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.