Gather Feasibility Data and User Feedback on Use of a Device in Vivo on Pregnant Volunteers in Their 2nd and 3rd TrimesterNCT03617419

Vscan Access R2 Feasibility Evaluation

A study testing GE VScan Access R2 Ultrasound System and GE Corometrics 170 Series Fetal Monitor in people with Gather Feasibility Data and User Feedback on Use of a Device in Vivo on Pregnant Volunteers in Their 2nd and 3rd Trimester, run by GE Healthcare at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Gather Feasibility Data and User Feedback on Use of a Device in Vivo on Pregnant Volunteers in Their 2nd and 3rd Trimester
What is being tested?: GE VScan Access R2 Ultrasound System and GE Corometrics 170 Series Fetal Monitor
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited States
Study dates: 14 Nov 2017to 26 Feb 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

GE Healthcare - Milwaukee County Research Park
Wauwatosa, Wisconsin, 53226-4856

Other trials in United States

About this study

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

Read the 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
Being tested: GE VScan Access R2 Ultrasound System, GE Corometrics 170 Series Fetal Monitor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT03617419
Study group	Role	What they receive
VScan Access R2 Ultrasound System	Other	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 Receives: Device: GE VScan Access R2 Ultrasound System; Device: GE Corometrics 170 Series Fetal Monitor

What is being measured

The primary outcome is the main question the study is designed to answer.

Difference in Fetal Heart Rate as Measured by VScan Access R2 and Corometrics
Absolute difference and variance in fetal heart rate (in BPM) measured using VScan Access R2 and Corometrics
Measured: 1 day - Up to 45 minutes of total scan time

Secondary outcomes (1)

GE Voluson P8 Confirmation of Visualization of Fetal Heart With Yes/No Answer Per Subject
Visualization of fetal heart as acquired from the GE Voluson P8 to verify that the fetal heart was correctly identified during the image acquisition using Vscan Access R2. This is gathered through a Yes/No confirmation by device operator as to whether it was the fetal heart being scanned (once for each subject).
Measured: 1 day - Up to 45 minutes of total scan time (5 minutes for this specific measurement)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Nov 201726 Feb 2018

First posted6 Aug 2018
Study start14 Nov 2017
Primary completion20 Nov 2017
Study completion26 Feb 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Gather Feasibility Data and User Feedback on Use of a Device in Vivo on Pregnant Volunteers in Their 2nd and 3rd TrimesterStudies of the same condition, open and under way.
More trials run by GE HealthcareThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Device feasibility
Intervention model: Sequential
Model description: 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).
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03617419
Sponsor's protocol ID: 110.05-2017-GES-0001
Status last verified: Apr 2019
First submitted: 1 Mar 2018
Last updated: 11 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Feasibility and Accuracy of Assisted Fetal Heart Rate (FHR) Feature of the GE Vscan Access R2 Ultrasound System
ClinicalTrials.gov ID: NCT03617419
Acronym / sponsor ID: 110.05-2017-GES-0001
Conditions: Gather Feasibility Data and User Feedback on Use of a Device in Vivo on Pregnant Volunteers in Their 2nd and 3rd Trimester
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: GE HealthcareIndustry (pharma, biotech, devices)
Study start: 14 Nov 2017 (actual)
Primary completion: 20 Nov 2017 (actual)
Study completion: 26 Feb 2018 (actual)
First posted: 6 Aug 2018 (actual)
Results: Posted 11 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Usability data will be gathered for further user experience optimization.

Study design

Primary purpose: Device feasibility
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1
Model description: 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).

Arm	Type	Receives
VScan Access R2 Ultrasound System	Other	Device: GE VScan Access R2 Ultrasound System, Device: GE Corometrics 170 Series Fetal MonitorPre-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

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GE VScan Access R2 Ultrasound SystemA diagnostic ultrasound imaging system manufactured by the study Sponsor.	Device	VScan Access R2 Ultrasound System
GE Corometrics 170 Series Fetal MonitorA reference device to record a continuous fetal heart rate.	Device	VScan Access R2 Ultrasound System
GE Corometrics 170 Series Fetal MonitorA reference device for verification of scanning the fetal heart.	Device	VScan Access R2 Ultrasound System

Primary outcome

Difference in Fetal Heart Rate as Measured by VScan Access R2 and Corometrics
Time frame: 1 day - Up to 45 minutes of total scan time
Absolute difference and variance in fetal heart rate (in BPM) measured using VScan Access R2 and Corometrics

1 secondary outcome

GE Voluson P8 Confirmation of Visualization of Fetal Heart With Yes/No Answer Per Subject
Time frame: 1 day - Up to 45 minutes of total scan time (5 minutes for this specific measurement)

Results and safety

Results posted to the registry on 11 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
VScan Access R2 Ultrasound System	2	2

Primary outcome: Difference in Fetal Heart Rate as Measured by VScan Access R2 and Corometrics

Time frame: 1 day - Up to 45 minutes of total scan time. Mean (Standard Deviation). Unit: Beats Per Minute (BPM)

Measure	VScan Access R2 Ultrasound System n = 14
Value	4.2 (4.13)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event collection period for duration of study scanning (~ one week).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
VScan Access R2 Ultrasound System	0 of 16 (0%)	0 of 16 (0%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in Fetal Heart Rate as Measured by VScan Access R2 and Corometrics (time frame: 1 day - Up to 45 minutes of total scan time). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03617419.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2019.