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NCT06281639 Clinical Trial

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

Congenital Heart Disease Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06281639
Other study ID # RAPID
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2024
Est. completion date April 1, 2025

Study information
Verified date April 2024
Source University of Minnesota
Contact Gwenyth Fischer, MD
Phone 6126256678
Email fisch662@umn.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date April 1, 2025
Est. primary completion date April 1, 2025
Accepts healthy volunteers
Gender All
Age group N/A to 1 Year
Eligibility Inclusion Criteria: - <1 years old - Be a patient at Masonic Children's Hospital or Masonic Children's Heart Center clinic undergoing PCU Exclusion Criteria: - Open Chest - On ECMO - Deemed medically unstable by care team - Cardiology, ICU, hospitalist or bedside nurse concerns

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (1)
Lead Sponsor Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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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