Optically Pumped 4He Magnetometers Performances Compared... | NCT02389257

Studies
Optically Pumped 4He Magnetometers Performances Compared With Medical Reference Methods (ECG and MEG)

NCT02389257

Sponsor

University Hospital, Grenoble

Status

Terminated

Last Update Posted

Oct 2, 2017Actual

Enrollment

1Actual

Phase

Phase 1

Conditions

Healthy

Interventions

MINIMAG / MEG
MINIMAG / ECG

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015Actual

Primary Completion Date

Jul 2017Actual

Completion Date

Sep 2017Actual

First Submitted Date

Jan 8, 2015

First Submission Date that Met QC Criteria

Mar 16, 2015

First Posted Date

Mar 17, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 27, 2017

Last Update Posted Date

Oct 2, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MINIMAG / MEG	Experimental	Cerebral magnetic fields	Device: MINIMAG / MEG
MINIMAG / ECG	Experimental	Cardiac magnetic fields	Device: MINIMAG / ECG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MINIMAG / MEG	Device		MINIMAG / MEG
MINIMAG / ECG

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants with Adverse EventsMagnetic brain or cardiac activity	Measure of Safety and Tolerability	1 year

Secondary Outcomes

Measure	Description	Time Frame
Brain or cardiac magnetic activity (Cerebral or cardiac magnetic fields record)	Cerebral or cardiac magnetic fields record	1 hour

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
CLINATEC		Grenoble		38000	France

Intervention Browse Module

MeSH Terms

ID	Term
D015225	Magnetoencephalography
D004562	Electrocardiography

Ancestor Terms

ID	Term
D003943	Diagnostic Techniques, Neurological
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D004568	Electrodiagnosis

Browse Leaves

Not provided

Browse Branches

Not provided