Vscan Access R2 Feasibility Evaluation

Completed · Not applicable

Conditions studied: Gather Feasibility Data and User Feedback on Use of a Device in Vivo on Pregnant Volunteers in Their 2nd and 3rd Trimester

In brief

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.

Key facts

Study ID

NCT03617419

Run by

GE Healthcare

People needed

16

Starts

2017-11-14

Expected to finish

2018-02-26

Last updated by the study team

2019-07-11

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GE Healthcare - Milwaukee County Research Park — Wauwatosa, Wisconsin, United States

Full record on ClinicalTrials.gov

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