Patient SatisfactionPRIMENCT06930534
Portable Rapid Imaging for Medical Emergencies
A study testing Swoop Plus Mk2.0 in people with Patient Satisfaction and Conventional Magnetic Resonance Imaging, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Satisfaction, Conventional Magnetic Resonance Imaging, Portable Magnetic Resonance Imaging
- What is being tested?
- Swoop Plus Mk2.0
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2025to 3 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Health Emergency Department
New Haven, Connecticut, 06520
About this study
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.
Read the 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
- Being tested
- Swoop Plus Mk2.0
- Keywords
- Brain MRI
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swoop Plus Mk2.0Device
portable brain MRI scanner
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediately post MRI (Day 1)
Secondary outcomes (4)
Portable MRI Findings
The frequency of acute findings (e.g., ischemic stroke, intracranial hemorrhage) using the portable MRI will be compared between groups.
Measured: immediately post MRI (Day 1)
Length of Stay
Total Emergency Department length of stay
Measured: immediately post MRI (Day 1)
Non-Completed Scans
To document the reasons for non-completion of MRI scans
Measured: 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.
Measured: immediately post MRI (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start21 Apr 2025
- Primary completion3 Dec 2025
- Study completion3 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Hyperfine
- Responsible party
- Sponsor
- Investigators
- Adam de Havenon, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06930534
- Sponsor's protocol ID
- 2000039013
- Acronym
- PRIME
- Status last verified
- Aug 2026
- First submitted
- 19 Mar 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Portable Rapid Imaging for Medical Emergencies
- ClinicalTrials.gov ID
- NCT06930534
- Acronym / sponsor ID
- PRIME / 2000039013
- Conditions
- Patient Satisfaction, Conventional Magnetic Resonance Imaging, Portable Magnetic Resonance Imaging
- Keywords
- Brain MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Hyperfine
- Study start
- 21 Apr 2025 (actual)
- Primary completion
- 3 Dec 2025 (actual)
- Study completion
- 3 Dec 2025 (actual)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Portable Brain MRI scan | Experimental | Device: Swoop Plus Mk2.0Participants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (18 listed)
- Lack of assent from treating physician for inclusion in this protocol.
- Contraindications to 1.5T MRI evaluation, including:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Swoop Plus Mk2.0portable brain MRI scanner | Device | Portable Brain MRI scan |
Primary outcome
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.
4 secondary outcomes
Portable MRI Findings
Time frame: immediately post MRI (Day 1)
Length of Stay
Time frame: immediately post MRI (Day 1)
Non-Completed Scans
Time frame: immediately post missed MRI (Day 1)
Time to scan during hospital encounter
Time frame: immediately post MRI (Day 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam de Havenon, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Swoop Plus Mk2.0 in people with Patient Satisfaction and Conventional Magnetic Resonance Imaging, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to start of scan (time frame: immediately post MRI (Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.