Fetal Heart Ultrasound Suspicious Radiographic Finding Identification - Reader Study

BrightHeart

Status: Completed

Conditions: Congenital Heart Disease

Treatments: Device: Device-Aided performances; Other: Device-Unaided performances

Study type: Observational

Funder types: Industry

Identifiers

NCT06392555

reader2024

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

200 participants in 1 patient group

Prenatal ultrasound examinations

Treatment:

Other: Device-Unaided performances

Device: Device-Aided performances