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 range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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