MedTrace Logo

Fetal Heart Ultrasound Suspicious Radiographic Finding Identification - Reader Study

NCT06392555 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2024-08-09

No results posted yet for this study

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

Interventions

DEVICE

Device-Aided performances

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

OTHER

Device-Unaided performances

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

Sponsors & Collaborators

  • BrightHeart

    lead INDUSTRY

Principal Investigators

  • Christophe Gardella, PhD · Chief Technical Officer

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-03
Primary Completion
2024-07-30
Completion
2024-07-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06392555 on ClinicalTrials.gov