Portable Rapid Imaging for Medical Emergencies (PRIME)

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.

Study Overview

• Status: Completed
• Conditions: Patient Satisfaction; Conventional Magnetic Resonance Imaging; Portable Magnetic Resonance Imaging
• Intervention / Treatment: Device: Swoop Plus Mk2.0

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale New Haven Health Emergency Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female ≥ 18 years of age at presentation to Yale New Haven Hospital Adult ED
• Order to receive conventional brain MRI imaging originating in the YNHH Adult ED

Exclusion Criteria:

• Lack of assent from treating physician for inclusion in this protocol.

• Contraindications to 1.5T MRI evaluation, including:

  1. Cardiac Pacemaker or defibrillator
  2. Aneurysm clip

  3. Implants or devices attached to the body in the chest or above, such as:

     1. Nerve stimulator
     2. Deep brain stimulator
     3. Programmable shunt
     4. Stent
     5. Pain pump
     6. Artificial extremity
  4. Implants in the ears (hearing aid or cochlear implant
  5. Any shrapnel, pellets, bullets, metallic fragments, or other metallic foreign body above the chest
  6. Metallic joints, rods, screws, or other orthopedic implants in or above the chest
  7. Braces, dentures, removable teeth, or dental expanders that cannot be removed.
  8. Body piercings in or above the chest that cannot be removed.
  9. MRI-incompatible Tracheostomy tube or Swan Ganz catheter in place
  10. Status Epilepticus or anyone previously seizing deemed by the physician not to be suitable for pMRI

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Portable Brain MRI scan; Participants in the scan arm will receive a portable MRI scan as soon as the scanner is available after randomization as part of their initial evaluation. Regardless of randomization arm, all participants will receive their scheduled conventional MRI as usual.	Device: Swoop Plus Mk2.0; portable brain MRI scanner
No Intervention: Standard of Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to start of scan	The primary outcome is time from MRI order to assigned arm scan initiation, analyzed as cumulative initiation at the prespecified time points of 3,6,9, and 12 hours.	immediately post MRI (Day 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Portable MRI Findings	The frequency of acute findings (e.g., ischemic stroke, intracranial hemorrhage) using the portable MRI will be compared between groups.	immediately post MRI (Day 1)
Length of Stay	Total Emergency Department length of stay	immediately post MRI (Day 1)
Non-Completed Scans	To document the reasons for non-completion of MRI scans	immediately post missed MRI (Day 1)
Time to scan during hospital encounter	Time in hours from MRI order to scan initiation among participants whose assigned examination was initiated during the same hospital encounter.	immediately post MRI (Day 1)

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: Hyperfine
• Investigators: Principal Investigator: Adam de Havenon, MD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2025
• Primary Completion (Actual): December 3, 2025
• Study Completion (Actual): December 3, 2025

Study Registration Dates

• First Submitted: March 19, 2025
• First Submitted That Met QC Criteria: April 8, 2025
• First Posted (Actual): April 16, 2025

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Brain MRI
• Additional Relevant MeSH Terms: Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Satisfaction
• Other Study ID Numbers: 2000039013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No