Trial Outcomes & Findings for Vscan Access R2 Feasibility Evaluation (NCT NCT03617419)

NCT ID: NCT03617419

Last Updated: 2019-07-11

Results Overview

Absolute difference and variance in fetal heart rate (in BPM) measured using VScan Access R2 and Corometrics

Recruitment status

COMPLETED

Study phase

Target enrollment

16 participants

Primary outcome timeframe

1 day - Up to 45 minutes of total scan time

Results posted on

2019-07-11

Participant Flow

Participant milestones

Participant milestones
Measure	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 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.
Part 1 STARTED	2
Part 1 COMPLETED	2
Part 1 NOT COMPLETED	0
Part 2 STARTED	14
Part 2 COMPLETED	14
Part 2 NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vscan Access R2 Feasibility Evaluation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VScan Access R2 Ultrasound System n=14 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Trimester (2nd or 3rd) 2nd Trimester of Pregnancy	8 Participants n=5 Participants
Trimester (2nd or 3rd) 3rd Trimester of Pregnancy	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	VScan Access R2 Ultrasound System n=14 Participants 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.
Difference in Fetal Heart Rate as Measured by VScan Access R2 and Corometrics	4.2 Beats Per Minute (BPM) Standard Deviation 4.13

SECONDARY outcome

Timeframe: 1 day - Up to 45 minutes of total scan time (5 minutes for this specific measurement)

Population: Subjects in Part 1 (2) and Part 2 (14)

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).

Outcome measures

Outcome measures
Measure	VScan Access R2 Ultrasound System n=16 Participants 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.
GE Voluson P8 Confirmation of Visualization of Fetal Heart With Yes/No Answer Per Subject	16 "Yes" responses

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	VScan Access R2 Ultrasound System n=16 Participants 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.
Number of Adverse Events (AE/SAE) Reported During Study	0 AEs / SAEs Reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 10 minute survey completed by scan operators upon completion their participation (only one day per user)

Population: Device Operators

Series of nine questions regarding usability, ease of use, and workflow

Outcome measures

Outcome measures
Measure	VScan Access R2 Ultrasound System n=9 Participants 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.
Number of Scan Operators Who Completed Surveys Regarding Usability of Vscan Access R2 Device	9 Completed Usability Surveys

OTHER_PRE_SPECIFIED outcome

Timeframe: Three weeks (estimated study duration)

Device Issues, Complaints, and Malfunctions will be reported in a table (type and number)

Outcome measures

Outcome measures
Measure	VScan Access R2 Ultrasound System n=16 Participants 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.
Number of Device Issues/Complaints Reported by Site	0 Device Malfunctions

Adverse Events

VScan Access R2 Ultrasound System

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sr. Clinical Affairs Project Manager

GE Healthcare

Phone: 2624095722

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place