Portable Rapid Imaging for Medical Emergencies

NCT ID: NCT06930534

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-21
• Study Completion Date: 2026-04-30

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Swoop Plus Mk2.0

Intervention Type: DEVICE

portable brain MRI scanner

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Swoop Plus Mk2.0

portable brain MRI scanner

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hyperfine

INDUSTRY

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adam de Havenon, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale New Haven Health Emergency Department

New Haven, Connecticut, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Adam H de Havenon, MD

Role: CONTACT

adam.dehavenon@yale.edu

203-785-4085

Other Identifiers

2000039013

Identifier Type: -

Identifier Source: org_study_id