VolunteersMRI HBNCT02942667
Magnetic Resonance Imaging of Human Biometrics
An observational study of Volunteers, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in United States.
Trial summary
The primary objective is to collect high quality MRI data (un-processed or processed) from participating subjects for Medtronic research purposes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Volunteers
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 2 Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will enroll up to 30 subjects at up to 5 study sites in the US.
Who may be able to join
- Subject is at least 18 years of age
- Subject is willing and able to undergo study requirements
Who cannot join
- 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:
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective is to collect high quality MRI data (un-processed or processed) from participating subjects for Medtronic research purposes.
- Conditions
- Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subjects undergoing high quality MRI Scans | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect High Quality MRI Data
Measured: Approximately 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study startAug 2016
- Primary completion6 Dec 2017
- Study completion2 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VolunteersStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02942667
- Sponsor's protocol ID
- MRI HB
- Acronym
- MRI HB
- Status last verified
- Feb 2018
- First submitted
- 30 Sep 2016
- Last updated
- 7 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging of Human Biometrics
- ClinicalTrials.gov ID
- NCT02942667
- Acronym / sponsor ID
- MRI HB / MRI HB
- Conditions
- Volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Aug 2016 (actual)
- Primary completion
- 6 Dec 2017 (actual)
- Study completion
- 2 Feb 2018 (actual)
- First posted
- 24 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to collect high quality MRI data (un-processed or processed) from participating subjects for Medtronic research purposes.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects undergoing high quality MRI Scans | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll up to 30 subjects at up to 5 study sites in the US.
Key inclusion criteria (2 listed)
- Subject is at least 18 years of age
- Subject is willing and able to undergo study requirements
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Collect High Quality MRI Data
Time frame: Approximately 6 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2018.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Volunteers, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collect High Quality MRI Data (time frame: Approximately 6 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2018.