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The primary objective is to collect high quality MRI data (un-processed or processed) from participating subjects for Medtronic research purposes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects undergoing high quality MRI Scans |
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| Measure | Description | Time Frame |
|---|---|---|
| Collect High Quality MRI Data | Approximately 6 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
Subject has a medical condition that precludes the subject from participation
Subject has any magnetizable foreign object (e.g. jewelry) which cannot be removed for the duration of the study
Subject is claustrophobic
Subject is unable to stand without assistance
Subject requires sedation for MRI scans
Subject is implanted with non-Magnetic Resonance conditional or other medical device:
Subject has a cochlear implant, middle ear prosthesis, or has had ear surgery
Subject has ocular foreign bodies (i.e. metal shavings)
Subject has any type of device held in place by a magnet (i.e. dentures)
Subject has an insulin pump
Subject has metal shrapnel
Subject is pregnant or lactating
Subject has magnetizable implant
Subject requires legally authorized representative to sign Patient Informed Consent (PIC)/ Informed Consent (IC) form
Subject has other contraindication for an MRI scan as defined by the study site
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The study will enroll up to 30 subjects at up to 5 study sites in the US.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Winston-Salem | North Carolina | United States |
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