Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-02-26 @ 6:53 AM
Study NCT ID:
NCT02942667
Status:
COMPLETED
Last Update Posted:
2018-02-07
First Post:
2016-09-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnetic Resonance Imaging of Human Biometrics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-02-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-06', 'studyFirstSubmitDate': '2016-09-30', 'studyFirstSubmitQcDate': '2016-10-21', 'lastUpdatePostDateStruct': {'date': '2018-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Collect High Quality MRI Data', 'timeFrame': 'Approximately 6 Weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Volunteers']}, 'descriptionModule': {'briefSummary': 'The primary objective is to collect high quality MRI data (un-processed or processed) from participating subjects for Medtronic research purposes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will enroll up to 30 subjects at up to 5 study sites in the US.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is at least 18 years of age\n* Subject is willing and able to undergo study requirements\n\nExclusion Criteria:\n\n* Subject has a medical condition that precludes the subject from participation\n* Subject has any magnetizable foreign object (e.g. jewelry) which cannot be removed for the duration of the study\n* Subject is claustrophobic\n* Subject is unable to stand without assistance\n* Subject requires sedation for MRI scans\n* Subject is implanted with non-Magnetic Resonance conditional or other medical device:\n\n * Non-MRI conditional pacemaker, Implantable Cardiac Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT), or an implantable hemodynamic monitor\n * Metal clips (i.e. brain aneurysm clip)\n * Artificial heart valve\n * Implanted neural stimulator\n * Gastric capsule camera\n * Swan Ganz catheter\n * Stent\n * Inferior Vena Cava (IVC) filter\n * Orthopedic implant\n * Eye prosthesis\n * Vascular access port\n * Penile prosthesis\n * Intrauterine device\n* Subject has a cochlear implant, middle ear prosthesis, or has had ear surgery\n* Subject has ocular foreign bodies (i.e. metal shavings)\n* Subject has any type of device held in place by a magnet (i.e. dentures)\n* Subject has an insulin pump\n* Subject has metal shrapnel\n* Subject is pregnant or lactating\n* Subject has magnetizable implant\n* Subject requires legally authorized representative to sign Patient Informed Consent (PIC)/ Informed Consent (IC) form\n* Subject has other contraindication for an MRI scan as defined by the study site'}, 'identificationModule': {'nctId': 'NCT02942667', 'acronym': 'MRI HB', 'briefTitle': 'Magnetic Resonance Imaging of Human Biometrics', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiac Rhythm and Heart Failure'}, 'officialTitle': 'Magnetic Resonance Imaging of Human Biometrics', 'orgStudyIdInfo': {'id': 'MRI HB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects undergoing high quality MRI Scans'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Cardiac Rhythm and Heart Failure', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}