ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-07-21
Study Completion:2025-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06281639

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 1 Year
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * \<1 years old
  2. * Be a patient at Masonic Children's Hospital or Masonic Children's Heart Center clinic undergoing PCU
  1. * Open Chest
  2. * On ECMO
  3. * Deemed medically unstable by care team
  4. * Cardiology, ICU, hospitalist or bedside nurse concerns

Contacts and Locations

Principal Investigator

Gwenyth Fischer, MD
PRINCIPAL_INVESTIGATOR
University of Minnesota

Study Locations (Sites)

University of Minnesota
Minneapolis, Minnesota, 55414
United States

Collaborators and Investigators

Sponsor: University of Minnesota

  • Gwenyth Fischer, MD, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-21
Study Completion Date2025-10-01

Study Record Updates

Study Start Date2024-07-21
Study Completion Date2025-10-01

Terms related to this study

Additional Relevant MeSH Terms

  • Congenital Heart Disease