Fetal Heart Ultrasound Suspicious Radiographic Finding Identification - Reader Study

Completed

Conditions studied: Congenital Heart Disease

In brief

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.

Key facts

Study ID

NCT06392555

Run by

BrightHeart

People needed

200

Starts

2024-05-03

Expected to finish

2024-07-30

Last updated by the study team

2024-08-09

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• MFM Associates, PLLC — New York, New York, United States

Full record on ClinicalTrials.gov

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