Fetal Heart Ultrasound Suspicious Radiographic Finding Identification - Reader Study

NCT06392555 | Completed FDA Device

• 1 other identifier: reader2024
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

• AUC of the ROC curve for the presence of any suspicious finding

  AUC of the ROC curve for both reading conditions (aided vs unaided by the device) derived from the identification of any suspicious radiographic finding

  1 month

Secondary Outcomes (3)

• AUC of the ROC curve for the presence of each suspicious finding

  1 month

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

  1 month

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

  1 month

Study Arms (1)

Prenatal ultrasound examinations

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

Interventions

Device-Aided performances DEVICE

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

Prenatal ultrasound examinations

Device-Unaided performances OTHER

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

Prenatal ultrasound examinations

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Ultrasound examinations conducted during the second trimester of the pregnancy, containing interpretable 4-chamber, LVOT and ROVT standard views of the fetal heart

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

Sponsors & Collaborators

• BrightHeart: lead

Study Sites (1)

MFM Associates, PLLC

New York, New York, 10128, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Christophe Gardella, PhD

  Chief Technical Officer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: April 30, 2024
• Study Start: May 3, 2024
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)