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Completed

NCT Number: NCT06392555

Fetal Heart Ultrasound Suspicious Radiographic Finding Identification - Reader Study

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.

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

MFM Associates, PLLC

New York, 10128, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Device-Aided performances

Device

Determination of the presence of the 8 findings suspicious of CHD by readers, aided by the device

Device-Unaided performances

Other

Determination of the presence of the 8 findings suspicious of CHD by readers, unaided by the device

Primary outcomes

  1. AUC of the ROC curve for the presence of any suspicious finding

    Time frame: 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 outcomes

  1. AUC of the ROC curve for the presence of each suspicious finding

    Time frame: 1 month

    AUCs of the ROC curve for both reading conditions (aided vs unaided by the device) for identification of each finding.

  2. Sensitivity and specificity for both reading conditions for the presence of any suspicious finding

    Time frame: 1 month

    Sensitivity and specificity for both reading conditions (aided vs unaided by the device) for identification of each finding.

  3. Sensitivity and specificity for both reading conditions for the presence of each suspicious finding

    Time frame: 1 month

    Sensitivity and specificity for both reading conditions for the presence of each suspicious finding.

Sponsors and collaborators

Lead sponsor

BrightHeart

Industry

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 30, 2024
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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