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This study will compare the time it takes to scan a patient in the emergency department with a portable MRI when compared to a conventional MRI. Participants will be randomized to receive a portable MRI plus standard of care (SOC) vs SOC. Investigators will look at time to beginning of scan for both.
The primary objective of this study is to determine whether portable brain MRI reduces the time from scan order to scan start in the emergency department as compared to conventional brain MRI. The secondary objectives of this study are 1) to measure the percentage of scans that are completed after order and the time from order to completion, 2) to compare findings on portable MRI to conventional brain imaging findings, 3) to compare the total length of stay between the portable MRI and conventional MRI groups, and 4) to understand the impact of portable MRI scans on decision making and provider satisfaction based on qualitative surveys administered to a physician endpoint panel. This is a prospective, observational, randomized study. Participants will be recruited from the pool of patients ordered for a brain MRI, with or without contrast and excluding hyperacute MRI, in the emergency department. Participants will be randomized to one of two treatment groups, scan or standard-of-care (SOC). Participants in the scan arm will receive a portable MRI scan as soon as the scanner is available after randomization. Participants in the SOC arm will not receive a portable MRI scan as part of their initial evaluation. Regardless of randomization arm, all participants will receive their scheduled conventional MRI as usual. Information on each participant's clinical course, conventional imaging, and length of stay will be collected, regardless of treatment group. On a rolling basis, surveys containing deidentified clinical information and portable MRI scans will be administered to a physician panel to assess the impact of portable MRI scans on decision making and provider satisfaction.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Yale New Haven Health Emergency Department
New Haven, Connecticut, United States
Start Date
April 21, 2025
Primary Completion Date
April 1, 2026
Completion Date
April 1, 2026
Last Updated
August 20, 2025
300
ESTIMATED participants
Swoop Plus Mk2.0
DEVICE
Lead Sponsor
Yale University
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06100978