MedTrace Logo

RAPID: a Comparison Study of a Novel Ultrasound Device of Automated Congenital Heart Imaging

NCT06281639 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 22

Last updated 2026-02-23

No results posted yet for this 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.

Conditions

  • Congenital Heart Disease

Interventions

DEVICE

RAPID

test the clinical screening potential for congenital heart disorders using a single ECHO image taken by the RAPID device

Sponsors & Collaborators

Principal Investigators

  • Gwenyth Fischer, MD · University of Minnesota

Eligibility

Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-21
Primary Completion
2025-08-28
Completion
2025-08-28
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06281639 on ClinicalTrials.gov