- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02389257
Optically Pumped 4He Magnetometers Performances Compared With Medical Reference Methods (ECG and MEG) (MINIMAG)
September 27, 2017 updated by: University Hospital, Grenoble
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Optically Pumped 4He Magnetometers vs reference sensors electrocardiogram (ECG) or SQUIDs data acquisitions
Study Type
Interventional
Enrollment (Actual)
1
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Grenoble, France, 38000
- CLINATEC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MINIMAG / MEG
Cerebral magnetic fields
|
|
|
Experimental: MINIMAG / ECG
Cardiac magnetic fields
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants with Adverse EventsMagnetic brain or cardiac activity
Time Frame: 1 year
|
Measure of Safety and Tolerability
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brain or cardiac magnetic activity (Cerebral or cardiac magnetic fields record)
Time Frame: 1 hour
|
Cerebral or cardiac magnetic fields record
|
1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2015
Primary Completion (Actual)
July 1, 2017
Study Completion (Actual)
September 1, 2017
Study Registration Dates
First Submitted
January 8, 2015
First Submitted That Met QC Criteria
March 16, 2015
First Posted (Estimate)
March 17, 2015
Study Record Updates
Last Update Posted (Actual)
October 2, 2017
Last Update Submitted That Met QC Criteria
September 27, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MINIMAG
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.