Portable Rapid Imaging for Medical Emergencies

NCT06930534 | Recruiting FDA Device

• 1 other identifier: 2000039013
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Patient Satisfaction; Conventional Magnetic Resonance Imaging; Portable Magnetic Resonance Imaging

Keywords

Brain MRI

Outcome Measures

Primary Outcomes (1)

• Time to start of scan

  Time from brain MRI order to start of scan, either portable or conventional.

  immediately post MRI (Day 1)

Secondary Outcomes (5)

• Percentage of Completed Scans

  immediately post MRI (Day 1)

• Portable MRI Findings

  immediately post MRI (Day 1)

• Length of Stay

  immediately post MRI (Day 1)

• Provider Satisfaction Survey

  immediately post MRI (Day 1)

• Non-Completed Scans

  immediately post missed MRI (Day 1)

Study Arms (2)

Portable Brain MRI scan

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

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.

Interventions

Swoop Plus Mk2.0 DEVICE

portable brain MRI scanner

Portable Brain MRI scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• Hyperfine: collaborator

Study Sites (1)

Yale New Haven Health Emergency Department

New Haven, Connecticut, 06520, United States

RECRUITING

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Adam de Havenon, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adam H de Havenon, MD

CONTACT

203-785-4085; adam.dehavenon@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: April 16, 2025
• Study Start: April 21, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)