Fetal Heart Ultrasound Suspicious Radiographic Finding Identification - Reader Study
NCT ID: NCT06392555
Last Updated: 2024-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
200 participants
OBSERVATIONAL
2024-05-03
2024-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Prenatal ultrasound examinations
Device-Aided performances
Determination of the presence of the 8 findings suspicious of CHD by readers, aided by the device
Device-Unaided performances
Determination of the presence of the 8 findings suspicious of CHD by readers, unaided by the device
Interventions
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Device-Aided performances
Determination of the presence of the 8 findings suspicious of CHD by readers, aided by the device
Device-Unaided performances
Determination of the presence of the 8 findings suspicious of CHD by readers, unaided by the device
Eligibility Criteria
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Inclusion Criteria
* fetus between 18 and 24 weeks of gestational age
* mothers 18 years old or older
Exclusion Criteria
* 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
18 Years
FEMALE
Yes
Sponsors
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BrightHeart
INDUSTRY
Responsible Party
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Principal Investigators
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Christophe Gardella, PhD
Role: STUDY_DIRECTOR
Chief Technical Officer
Locations
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MFM Associates, PLLC
New York, New York, United States
Countries
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Other Identifiers
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reader2024
Identifier Type: -
Identifier Source: org_study_id
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