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Vscan Access R2 Feasibility Evaluation

NCT03617419 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2019-07-11

Study results available
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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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • GE Healthcare

    lead INDUSTRY

Study Design

Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-14
Primary Completion
2017-11-20
Completion
2018-02-26
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03617419 on ClinicalTrials.gov