Trials / Completed
CompletedNCT06392555
Fetal Heart Ultrasound Suspicious Radiographic Finding Identification - Reader Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 200 (actual)
- Sponsor
- BrightHeart · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2024-05-03
- Primary completion
- 2024-07-30
- Completion
- 2024-07-30
- First posted
- 2024-04-30
- Last updated
- 2024-08-09
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06392555. Inclusion in this directory is not an endorsement.