Winston-Salem, North Carolina, United States
NCT Number: NCT02942667
Magnetic Resonance Imaging of Human Biometrics
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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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Collect High Quality MRI Data
Time frame: Approximately 6 Weeks
Sponsors and collaborators
Lead sponsor
Medtronic Cardiac Rhythm and Heart Failure
Industry
Registry information
Acronym: MRI HB
Important dates
- Study start
- 2016
- Primary completion
- 2017
- Study completion
- 2018
- First posted
- Oct 24, 2016
- Registry last updated
- Feb 7, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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