CompletedNot Applicable

Vscan Access R2 Feasibility Evaluation

United States16 participantsStarted 2017-11-14

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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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.

What they're measuring

Difference in Fetal Heart Rate as Measured by VScan Access R2 and Corometrics

Timeframe: 1 day - Up to 45 minutes of total scan time

Trial details

NCT IDNCT03617419

SponsorGE Healthcare

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-11-20

Results submitted2018-12-10

View on ClinicalTrials.gov More Gather Feasibility Data and User Feedback on Use of a Device in Vivo on Pregnant Volunteers in Their 2nd and 3rd Trimester trials