HealthyPhase 1MINIMAGNCT02389257
Optically Pumped 4He Magnetometers Performances Compared With Medical Reference Methods (ECG and MEG)
A Phase 1 study testing MINIMAG / MEG and MINIMAG / ECG in people with Healthy, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Optically Pumped 4He Magnetometers operability for cerebral and cardiac magnetic fields measurement. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MINIMAG / MEG and MINIMAG / ECG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Sep 2017
- Phase
- Phase 1
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- more or equal than 18 years old
- patient affiliated to social security or similarly regime
- informed consent form signed
- without cardiac, neurologic, psychiatric or metabolic medical history.
Who cannot join
- Pregnant women and lactating mothers
- Ward of court or under guardianship
- Adult unable to express their consent
- Person deprived of freedom by judicial or administrative decision
- Person hospitalized without their consent
- Person under legal protection
- Person with any implant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optically Pumped 4He Magnetometers Performances Compared With Medical Reference Methods : Electrocardiography (ECG) and Magnetoencephalography (MEG)
Optically Pumped 4He Magnetometers operability for cerebral and cardiac magnetic fields measurement.
Read the detailed description
Optically Pumped 4He Magnetometers vs reference sensors electrocardiogram (ECG) or SQUIDs data acquisitions
- Conditions
- Healthy
- Being tested
- MINIMAG / MEG, MINIMAG / ECG
- Keywords
- volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MINIMAG / MEGDevice
MINIMAG / ECGDevice
| Study group | Role | What they receive |
|---|---|---|
| MINIMAG / MEG | Experimental | Cerebral magnetic fields Receives: Device: MINIMAG / MEG |
| MINIMAG / ECG | Experimental | Cardiac magnetic fields Receives: Device: MINIMAG / ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse EventsMagnetic brain or cardiac activity
Measure of Safety and Tolerability
Measured: 1 year
Secondary outcomes (1)
Brain or cardiac magnetic activity (Cerebral or cardiac magnetic fields record)
Cerebral or cardiac magnetic fields record
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startJan 2015
- Primary completionJul 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02389257
- Sponsor's protocol ID
- MINIMAG
- Acronym
- MINIMAG
- Status last verified
- Sep 2017
- First submitted
- 8 Jan 2015
- Last updated
- 2 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optically Pumped 4He Magnetometers Performances Compared With Medical Reference Methods : Electrocardiography (ECG) and Magnetoencephalography (MEG)
- ClinicalTrials.gov ID
- NCT02389257
- Acronym / sponsor ID
- MINIMAG / MINIMAG
- Conditions
- Healthy
- Keywords
- volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 17 Mar 2015 (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.
Optically Pumped 4He Magnetometers operability for cerebral and cardiac magnetic fields measurement.
Detailed description
Optically Pumped 4He Magnetometers vs reference sensors electrocardiogram (ECG) or SQUIDs data acquisitions
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MINIMAG / MEG | Experimental | Device: MINIMAG / MEGCerebral magnetic fields |
| MINIMAG / ECG | Experimental | Device: MINIMAG / ECGCardiac magnetic fields |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- more or equal than 18 years old
- patient affiliated to social security or similarly regime
- informed consent form signed
- without cardiac, neurologic, psychiatric or metabolic medical history.
Key exclusion criteria (7 listed)
- Pregnant women and lactating mothers
- Ward of court or under guardianship
- Adult unable to express their consent
- Person deprived of freedom by judicial or administrative decision
- Person hospitalized without their consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MINIMAG / MEG | Device | MINIMAG / MEG |
| MINIMAG / ECG | Device | MINIMAG / ECG |
Primary outcome
Number of Participants with Adverse EventsMagnetic brain or cardiac activity
Time frame: 1 year
Measure of Safety and Tolerability
1 secondary outcome
Brain or cardiac magnetic activity (Cerebral or cardiac magnetic fields record)
Time frame: 1 hour
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
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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?
A Phase 1 study testing MINIMAG / MEG and MINIMAG / ECG in people with Healthy, run by University Hospital, Grenoble at 1 site in France.
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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 2 Oct 2017. 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 France. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Number of Participants with Adverse EventsMagnetic brain or cardiac activity (time frame: 1 year). 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 2 Oct 2017.