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NCT06281639 · ClinicalTrials.gov registry record
RAPID: a Comparison Study of a Novel Ultrasound Device of Automated Congenital Heart Imaging
A clinical trial, sponsored by University of Minnesota.
- Completed
- Registry status
- 22
- Enrollment target
NCT06281639: Completed study, sponsored by University of Minnesota.
NCT06281639 is a clinical trial that has completed, run by University of Minnesota. The registered enrollment target is 22 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06281639 has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- 22 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DEVICE RAPID
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2024-07-21 |
| Est. Completion | 2025-08-28 |
What the finished NCT06281639 record still lists
NCT06281639 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 22 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which RAPID is the first listed.
NCT06281639 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06281639 about?
NCT06281639 is a clinical study titled "RAPID: a Comparison Study of a Novel Ultrasound Device of Automated Congenital Heart Imaging". 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 patient...
What is the current status of trial NCT06281639?
This trial is currently completed. The enrollment target is 22 participants. The study started on 2024-07-21. Estimated completion is 2025-08-28.
What interventions are being tested in trial NCT06281639?
The interventions under investigation include: RAPID (DEVICE).
Who is sponsoring clinical trial NCT06281639?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
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