Trials / Completed
CompletedNCT06281639
RAPID: a Comparison Study of a Novel Ultrasound Device of Automated Congenital Heart Imaging
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 22 (actual)
- Sponsor
- University of Minnesota · Academic / Other
- Sex
- All
- Age
- 1 Year
- Healthy volunteers
- —
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | RAPID | test the clinical screening potential for congenital heart disorders using a single ECHO image taken by the RAPID device |
Timeline
- Start date
- 2024-07-21
- Primary completion
- 2025-08-28
- Completion
- 2025-08-28
- First posted
- 2024-02-28
- Last updated
- 2026-02-23
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06281639. Inclusion in this directory is not an endorsement.