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The RAPID ultrasound is a portable imaging device that captures a one point image from the subcostal region of the heart. The device is set on the patient's chest and captures the image in <1 minute. It uses ultrasound imaging energy that is similar to commercialized devices and safe for patients of all ages and sizes. The device is a non-significant risk and therefore will not require an IDE. Images from RAPID will be taken directly before or after the standard clinical PCU. Images taken from both the RAPID device and the standard PCU will be de-identified and stored securely in BOX for review by two independent cardiologists. Image reviews will be conducted within Box.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study group | Caregivers who have a child with a scheduled Pediatric congenital ultrasound (PCU) the day of recruitment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RAPID | Device | test the clinical screening potential for congenital heart disorders using a single ECHO image taken by the RAPID device |
|
| Measure | Description | Time Frame |
|---|---|---|
| RAPID imaging quality | comparing the result of the data and imaging collected from the gold standard (PCU) vs the prototype device (RAPID) Two independent cardiologists will review each de-identified image in a large batch of standardized images consisting of random images from both RAPID and PCU. Each image will be reviewed by the cardiologists based on a specific checklist | 30minutes |
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Inclusion Criteria:
Exclusion Criteria:
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children with a scheduled PCU the day of recruitment
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| Name | Affiliation | Role |
|---|---|---|
| Gwenyth Fischer, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55414 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 27, 2025 | Feb 19, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |