NCT03617419

Vscan Access R2 Feasibility Evaluation

Evaluation of Feasibility and Accuracy of Assisted Fetal Heart Rate (FHR) Feature of the GE Vscan Access R2 Ultrasound System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	GE VScan Access R2 Ultrasound System	A diagnostic ultrasound imaging system manufactured by the study Sponsor.
DEVICE	GE Corometrics 170 Series Fetal Monitor	A reference device to record a continuous fetal heart rate.
DEVICE	GE Corometrics 170 Series Fetal Monitor	A reference device for verification of scanning the fetal heart.

Timeline

• Start date: 2017-11-14
• Primary completion: 2017-11-20
• Completion: 2018-02-26
• First posted: 2018-08-06
• Last updated: 2019-07-11
• Results posted: 2019-07-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study