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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

Study Type Interventional
Study Design Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Device Feasibility
Condition 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
Device: GE Corometrics 170 Series Fetal Monitor
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title VScan Access R2 Ultrasound System
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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

GE VScan Access R2 Ultrasound System: A diagnostic ultrasound imaging system manufactured by the study Sponsor.

GE Corometrics 170 Series Fetal Monitor: A reference device to record a continuous fetal heart rate.

GE Corometrics 170 Series Fetal Monitor: A reference device for verification of scanning the fetal heart.

Period Title: Part 1
Started 2
Completed 2
Not Completed 0
Period Title: Part 2
Started 14
Completed 14
Not Completed 0
Arm/Group Title VScan Access R2 Ultrasound System
Hide Arm/Group Description

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

GE VScan Access R2 Ultrasound System: A diagnostic ultrasound imaging system manufactured by the study Sponsor.

GE Corometrics 170 Series Fetal Monitor: A reference device to record a continuous fetal heart rate.

GE Corometrics 170 Series Fetal Monitor: A reference device for verification of scanning the fetal heart.

Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
Data and results collected/analyzed for participants in active study phase (2). Pilot participant data not collected per study Protocol.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
<=18 years
0
   0.0%
Between 18 and 65 years
14
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
14
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
14
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Trimester (2nd or 3rd)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
2nd Trimester of Pregnancy
8
  57.1%
3rd Trimester of Pregnancy
6
  42.9%
1.Primary Outcome
Title Difference in Fetal Heart Rate as Measured by VScan Access R2 and Corometrics
Hide Description Absolute difference and variance in fetal heart rate (in BPM) measured using VScan Access R2 and Corometrics
Time Frame 1 day - Up to 45 minutes of total scan time
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VScan Access R2 Ultrasound System
Hide Arm/Group Description:

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

GE VScan Access R2 Ultrasound System: A diagnostic ultrasound imaging system manufactured by the study Sponsor.

GE Corometrics 170 Series Fetal Monitor: A reference device to record a continuous fetal heart rate.

GE Corometrics 170 Series Fetal Monitor: A reference device for verification of scanning the fetal heart.

Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: Beats Per Minute (BPM)
4.2  (4.13)
2.Secondary Outcome
Title GE Voluson P8 Confirmation of Visualization of Fetal Heart With Yes/No Answer Per Subject
Hide Description 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).
Time Frame 1 day - Up to 45 minutes of total scan time (5 minutes for this specific measurement)
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects in Part 1 (2) and Part 2 (14)
Arm/Group Title VScan Access R2 Ultrasound System
Hide Arm/Group Description:

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

GE VScan Access R2 Ultrasound System: A diagnostic ultrasound imaging system manufactured by the study Sponsor.

GE Corometrics 170 Series Fetal Monitor: A reference device to record a continuous fetal heart rate.

GE Corometrics 170 Series Fetal Monitor: A reference device for verification of scanning the fetal heart.

Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: "Yes" responses
16
3.Other Pre-specified Outcome
Title Number of Adverse Events (AE/SAE) Reported During Study
Hide Description Summary of type and number of AEs, SAEs reported/recorded during course
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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VScan Access R2 Ultrasound System
Hide Arm/Group Description:

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

GE VScan Access R2 Ultrasound System: A diagnostic ultrasound imaging system manufactured by the study Sponsor.

GE Corometrics 170 Series Fetal Monitor: A reference device to record a continuous fetal heart rate.

GE Corometrics 170 Series Fetal Monitor: A reference device for verification of scanning the fetal heart.

Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: AEs / SAEs Reported
0
4.Other Pre-specified Outcome
Title Number of Scan Operators Who Completed Surveys Regarding Usability of Vscan Access R2 Device
Hide Description Series of nine questions regarding usability, ease of use, and workflow
Time Frame 10 minute survey completed by scan operators upon completion their participation (only one day per user)
Hide Outcome Measure Data
Hide Analysis Population Description
Device Operators
Arm/Group Title VScan Access R2 Ultrasound System
Hide Arm/Group Description:

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

GE VScan Access R2 Ultrasound System: A diagnostic ultrasound imaging system manufactured by the study Sponsor.

GE Corometrics 170 Series Fetal Monitor: A reference device to record a continuous fetal heart rate.

GE Corometrics 170 Series Fetal Monitor: A reference device for verification of scanning the fetal heart.

Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: Completed Usability Surveys
9
5.Other Pre-specified Outcome
Title Number of Device Issues/Complaints Reported by Site
Hide Description Device Issues, Complaints, and Malfunctions will be reported in a table (type and number)
Time Frame Three weeks (estimated study duration)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VScan Access R2 Ultrasound System
Hide Arm/Group Description:

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

GE VScan Access R2 Ultrasound System: A diagnostic ultrasound imaging system manufactured by the study Sponsor.

GE Corometrics 170 Series Fetal Monitor: A reference device to record a continuous fetal heart rate.

GE Corometrics 170 Series Fetal Monitor: A reference device for verification of scanning the fetal heart.

Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: Device Malfunctions
0
Time Frame Adverse event collection period for duration of study scanning (~ one week).
Adverse Event Reporting Description Subject were monitored for AEs, SAEs, and UADEs during their study exams, until they exited the exam area. Procedures were conducted during a single visit (about one hour for each subject).
 
Arm/Group Title VScan Access R2 Ultrasound System
Hide Arm/Group Description

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

GE VScan Access R2 Ultrasound System: A diagnostic ultrasound imaging system manufactured by the study Sponsor.

GE Corometrics 170 Series Fetal Monitor: A reference device to record a continuous fetal heart rate.

GE Corometrics 170 Series Fetal Monitor: A reference device for verification of scanning the fetal heart.

All-Cause Mortality
VScan Access R2 Ultrasound System
Affected / at Risk (%)
Total   0/16 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
VScan Access R2 Ultrasound System
Affected / at Risk (%)
Total   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
VScan Access R2 Ultrasound System
Affected / at Risk (%)
Total   0/16 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sr. Clinical Affairs Project Manager
Organization: GE Healthcare
Phone: 2624095722
EMail: kevin.r.siewert@ge.com
Layout table for additonal information
Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT03617419     History of Changes
Other Study ID Numbers: 110.05-2017-GES-0001
First Submitted: March 1, 2018
First Posted: August 6, 2018
Results First Submitted: December 10, 2018
Results First Posted: July 11, 2019
Last Update Posted: July 11, 2019