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MRI HB: Magnetic Resonance Imaging of Human Biometrics

Sponsor
Medtronic Cardiac Rhythm and Heart Failure (Industry)
Overall Status
Completed
CT.gov ID
NCT02942667
Collaborator
(none)
12
Enrollment
1
Location
18.1
Actual Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective is to collect high quality MRI data (un-processed or processed) from participating subjects for Medtronic research purposes.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    12 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Magnetic Resonance Imaging of Human Biometrics
    Actual Study Start Date :
    Aug 1, 2016
    Actual Primary Completion Date :
    Dec 6, 2017
    Actual Study Completion Date :
    Feb 2, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    Subjects undergoing high quality MRI Scans

    Outcome Measures

    Primary Outcome Measures

    1. Collect High Quality MRI Data [Approximately 6 Weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Subject is at least 18 years of age

    • Subject is willing and able to undergo study requirements

    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:

    • Non-MRI conditional pacemaker, Implantable Cardiac Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT), or an implantable hemodynamic monitor

    • Metal clips (i.e. brain aneurysm clip)

    • Artificial heart valve

    • Implanted neural stimulator

    • Gastric capsule camera

    • Swan Ganz catheter

    • Stent

    • Inferior Vena Cava (IVC) filter

    • Orthopedic implant

    • Eye prosthesis

    • Vascular access port

    • Penile prosthesis

    • Intrauterine 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Winston-Salem North Carolina United States

    Sponsors and Collaborators

    • Medtronic Cardiac Rhythm and Heart Failure

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medtronic Cardiac Rhythm and Heart Failure
    ClinicalTrials.gov Identifier:
    NCT02942667
    Other Study ID Numbers:
    • MRI HB
    First Posted:
    Oct 24, 2016
    Last Update Posted:
    Feb 7, 2018
    Last Verified:
    Feb 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No

    Study Results

    No Results Posted as of Feb 7, 2018