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OpenTrials
Completed

NCT Number: NCT06930534

Portable Rapid Imaging for Medical Emergencies

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale New Haven Health Emergency Department

New Haven, Connecticut, 06520, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Cardiac Pacemaker or defibrillator
  • Aneurysm clip
  • Implants or devices attached to the body in the chest or above, such as:
  • Nerve stimulator
  • Deep brain stimulator
  • Programmable shunt
  • Stent
  • Pain pump
  • Artificial extremity
  • Implants in the ears (hearing aid or cochlear implant
  • Any shrapnel, pellets, bullets, metallic fragments, or other metallic foreign body above the chest
  • Metallic joints, rods, screws, or other orthopedic implants in or above the chest
  • Braces, dentures, removable teeth, or dental expanders that cannot be removed.
  • Body piercings in or above the chest that cannot be removed.
  • MRI-incompatible Tracheostomy tube or Swan Ganz catheter in place
  • Status Epilepticus or anyone previously seizing deemed by the physician not to be suitable for pMRI

Treatment and study plan

Swoop Plus Mk2.0

Device

portable brain MRI scanner

Primary outcomes

  1. Time to start of scan

    Time frame: immediately post MRI (Day 1)

    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.

Secondary outcomes

  1. Portable MRI Findings

    Time frame: immediately post MRI (Day 1)

    The frequency of acute findings (e.g., ischemic stroke, intracranial hemorrhage) using the portable MRI will be compared between groups.

  2. Length of Stay

    Time frame: immediately post MRI (Day 1)

    Total Emergency Department length of stay

  3. Non-Completed Scans

    Time frame: immediately post missed MRI (Day 1)

    To document the reasons for non-completion of MRI scans

  4. Time to scan during hospital encounter

    Time frame: immediately post MRI (Day 1)

    Time in hours from MRI order to scan initiation among participants whose assigned examination was initiated during the same hospital encounter.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Hyperfine

Registry information

Acronym: PRIME

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 16, 2025
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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