CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 16 enrolled
Drug / intervention
GE VScan Access R2 Ultrasound System +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03617419
NCT03617419N/ACompleted
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Evaluation of Feasibility and Accuracy of Assisted Fetal Heart Rate (FHR) Feature of the GE Vscan Access R2 Ultrasound System

GE Healthcare·interventional·Posted Aug 6, 2018·Updated Jul 11, 2019

In Brief

A clinical study evaluating GE VScan Access R2 Ultrasound System and GE Corometrics 170 Series Fetal Monitor for Gather Feasibility Data and User Feedback on Use of a Device in Vivo on Pregnant Volunteers in Their 2nd and 3rd Trimester. Completed, enrolled 16 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGather Feasibility Data and User Feedback on Use of a Device in Vivo on Pregnant Volunteers in Their 2nd and 3rd Trimester
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedAug 6, 2018
Enrollment StartNov 14, 2017
Primary CompletionNov 20, 2017
Study CompletionFeb 26, 2018
TodayJul 2, 2026
Enrollment to primary: 6 daysPosted 7.9 years ago

Interventions

GE VScan Access R2 Ultrasound Systemdevice

A diagnostic ultrasound imaging system manufactured by the study Sponsor.

GE Corometrics 170 Series Fetal Monitordevice

A reference device to record a continuous fetal heart rate.

GE Corometrics 170 Series Fetal Monitordevice

A reference device for verification of scanning the fetal heart.