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The purpose of the study is to collect in vivo human image data to demonstrate neurological magnetic resonance imaging (MRI) of subjects using short pulse sequences.
This is a single-site; open-label, prospective research Study involving human subjects. There will be no comparative efficacy or safety analysis and therefore no randomization
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pulse sequence software | Experimental | The central aim of this study is to acquire a set of images and associated technical and clinical information to facilitate regulatory submission of the pulse sequences being studied by GEHC. Segment 1 allows to collect a minimum of 10 subjects then evaluate if additional scans/enrollment needed Segment 2 will allow an additional 90 subjects if data needed |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pulse sequences | Device | Collect in vivo human data to demonstrate neurological Magnetic Resonance Imaging of subjects using a pulse sequence |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Head Images Successfully Collected | Collect head human images and associated technical and clinical information to demonstrate neurological magnetic resonance imaging of subjects using short pulse sequence. | 6-months |
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Inclusion Criteria:
Exclusion Criteria:
Subjects who have any of the conditions below at the time of the enrollment or scan session are excluded from this study. Further, should it be determined by study staff that an enrolled subject meets any of the conditions below during the course of the study, the subject will be removed from the study.
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| Name | Affiliation | Role |
|---|---|---|
| Mark C DeLano, MD | Corewell Health West | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spectrum Health | Grand Rapids | Michigan | 49503 | United States |
This is a single arm study.
Subjects with orders from their doctor for an MRI were screened from Spectrum Health's Neurology Department. The study coordinator contacts each subject that met the inclusion criteria. If the subject is interested to volunteer, a copy of the Informed Consent was sent and appointment scheduled. Seg. 1 enrolled 11 subjects; no Seg. 2 enrollment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm | Magnetic Resonance Images Collected Using Innovative Pulse Sequences : |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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images collected
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm | Magnetic Resonance Image Collection Using Innovative Pulse Sequences |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Head Images Successfully Collected | Collect head human images and associated technical and clinical information to demonstrate neurological magnetic resonance imaging of subjects using short pulse sequence. | Posted | Number | Images | 6-months | Images | Participants |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm | Magnetic Resonance Imaging Using Innovative Pulse Sequences : |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Charles DeLano, M.D., Principal Investigator | Spectrum Health | 616-363-7339 | delanom@msu.edu |
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|
| participants with images collected |
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| Sex/Gender, Customized | Number | participants with images collected |
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| Region of Enrollment | Number | particpants with images collected |
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| Images |
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| 0 |
| 11 |
| 0 |
| 11 |
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