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Vscan Access R2 Feasibility Evaluation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03617419
Recruitment Status : Completed
First Posted : August 6, 2018
Results First Posted : July 11, 2019
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
GE Healthcare

Brief 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.

Condition or disease Intervention/treatment Phase
Gather Feasibility Data and User Feedback on Use of a Device in Vivo on Pregnant Volunteers in Their 2nd and 3rd Trimester Device: GE VScan Access R2 Ultrasound System Device: GE Corometrics 170 Series Fetal Monitor Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Sequential Assignment
Intervention 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)
Primary Purpose: Device Feasibility
Official Title: Evaluation of Feasibility and Accuracy of Assisted Fetal Heart Rate (FHR) Feature of the GE Vscan Access R2 Ultrasound System
Actual Study Start Date : November 14, 2017
Actual Primary Completion Date : November 20, 2017
Actual Study Completion Date : February 26, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
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

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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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) ]
    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).


Other Outcome Measures:
  1. Number of Adverse Events (AE/SAE) Reported During Study [ Time Frame: Collected from the time subject signs informed consent form to the time of completion of subject's scan session, estimated up to 4 hours ]
    Summary of type and number of AEs, SAEs reported/recorded during course

  2. Number of Scan Operators Who Completed Surveys Regarding Usability of Vscan Access R2 Device [ Time Frame: 10 minute survey completed by scan operators upon completion their participation (only one day per user) ]
    Series of nine questions regarding usability, ease of use, and workflow

  3. Number of Device Issues/Complaints Reported by Site [ Time Frame: Three weeks (estimated study duration) ]
    Device Issues, Complaints, and Malfunctions will be reported in a table (type and number)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Study of pregnant volunteers
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03617419


Locations
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United States, Wisconsin
GE Healthcare - Milwaukee County Research Park
Wauwatosa, Wisconsin, United States, 53226-4856
Sponsors and Collaborators
GE Healthcare
  Study Documents (Full-Text)

Documents provided by GE Healthcare:

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Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT03617419     History of Changes
Other Study ID Numbers: 110.05-2017-GES-0001
First Posted: August 6, 2018    Key Record Dates
Results First Posted: July 11, 2019
Last Update Posted: July 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No