Fetal Heart Ultrasound Suspicious Radiographic Finding Identification - Reader Study

Completed

• Conditions: Congenital Heart Disease
• Interventions: Device: Device-Aided performances; Other: Device-Unaided performances

• Registration Number: NCT06392555
• Lead Sponsor: BrightHeart

Brief Summary

Clinical performance of the device will be evaluated in a fully-crossed, multiple-reader multiple-case (MRMC) study. This study will be used to determine the impact of the device on reader performance in identifying suspicious radiographic findings in fetal heart ultrasound video clips recorded during 2nd trimester anatomic ultrasound examinations conducted during the second trimester of the pregnancy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-26
• Study First Submitted QC: 2024-04-26
• Study First Posted: 2024-04-30
• Study Start: 2024-05-03
• Primary Completion: 2024-07-30
• Study Completion: 2024-07-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-08
• Last Update Posted: 2024-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• ultrasound examinations conducted during the second trimester of the pregnancy
• fetus between 18 and 24 weeks of gestational age
• mothers 18 years old or older

Exclusion Criteria

• exams corresponding to multiple pregnancy
• fetal heterotaxy
• exams not containing video clips with interpretable 4-chamber (4C), Left Ventricular Outflow Tract (LVOT) or Right Ventricular Outflow Tract (RVOT) standard views

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prenatal ultrasound examinations	Device-Aided performances	-
Prenatal ultrasound examinations	Device-Unaided performances	-

Primary Outcome Measures

Name	Time	Method
AUC of the ROC curve for the presence of any suspicious finding	1 month	AUC of the ROC curve for both reading conditions (aided vs unaided by the device) derived from the identification of any suspicious radiographic finding

Secondary Outcome Measures

Name	Time	Method
Sensitivity and specificity for both reading conditions for the presence of each suspicious finding	1 month	Sensitivity and specificity for both reading conditions for the presence of each suspicious finding.
Sensitivity and specificity for both reading conditions for the presence of any suspicious finding	1 month	Sensitivity and specificity for both reading conditions (aided vs unaided by the device) for identification of each finding.
AUC of the ROC curve for the presence of each suspicious finding	1 month	AUCs of the ROC curve for both reading conditions (aided vs unaided by the device) for identification of each finding.

Trial Locations

Locations (1)

MFM Associates, PLLC; 🇺🇸 New York, New York, United States