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

NCT ID: NCT06281639

Last Updated: 2025-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-21

Study Completion Date

2026-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Congenital Heart Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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study group

Caregivers who have a child with a scheduled Pediatric congenital ultrasound (PCU) the day of recruitment

RAPID

Intervention Type DEVICE

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

Interventions

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RAPID

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

Intervention Type DEVICE

Eligibility Criteria

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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
Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gwenyth Fischer, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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PEDS-2023-32532

Identifier Type: -

Identifier Source: org_study_id

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