Vscan Access R2 Feasibility Evaluation

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-14

Study Completion Date

2018-02-26

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Intervention Model

SEQUENTIAL

This study is being done to evaluate and gather feasibility data and user feedback on the use of the Vscan Access R2 device in vivo on pregnant volunteers in their 2nd and 3rd Trimester. The study will be conducted in two parts, including an initial pilot for determination of parameters (Part 1) and continued testing (Part 2).

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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VScan Access R2 Ultrasound System

Pre-market: Vscan Access R2 Ultrasound System

The following post-market products will be used on label:

GE Corometrics 170 Series Fetal Monitor - as a reference for value of fetal heart rate GE Voluson P8 Ultrasound System - for verification of fetal location during measurement

Group Type OTHER

GE VScan Access R2 Ultrasound System

Intervention Type DEVICE

A diagnostic ultrasound imaging system manufactured by the study Sponsor.

GE Corometrics 170 Series Fetal Monitor

Intervention Type DEVICE

A reference device to record a continuous fetal heart rate.

GE Corometrics 170 Series Fetal Monitor

Intervention Type DEVICE

A reference device for verification of scanning the fetal heart.

Interventions

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GE VScan Access R2 Ultrasound System

A diagnostic ultrasound imaging system manufactured by the study Sponsor.

Intervention Type DEVICE

GE Corometrics 170 Series Fetal Monitor

A reference device to record a continuous fetal heart rate.

Intervention Type DEVICE

GE Corometrics 170 Series Fetal Monitor

A reference device for verification of scanning the fetal heart.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Women aged 18 years or older at the time of consent;
2. By self-report, are in the 2nd or 3rd trimester of pregnancy;
3. Able and willing to provide written informed consent for participation;
4. 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

1. Are direct employees/contractors of General Electric (GE);
2. Are potentially put at additional risk by participating, in the opinion of study staff;
3. Twin pregnancies identified in patient medical history.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes