Validation of a Magnetic Sensor in Arterial Flow Recording, Compared With the Reference Method, at Various Peripheral Arterial Sites

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-02

Study Completion Date

2025-10-31

Brief Summary

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The measurement of magnetic fields emitted by cardiac activity has already been studied in magneto-cardiography. To date, however, this technology has never been evaluated in the peripheral circulation.

The magnetic susceptibility of iron in the circulating blood and the ionic currents in the blood stream generate a very weak induced magnetic current, which can be detected by the micro-sensor of the prototype investigators wish to study.

Proving the validity of this prototype would make it a new diagnostic and even prognostic tool, non-invasive, less costly and more accessible than Doppler for screening peripheral arterial disease.

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Detailed Description

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Conditions

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Lower Extremity Artery Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Magnetic sensor

The CapMagic device is a small magnetic sensor, whose technology is derived from magnetocardiography, with a very weak field identical to that of a refrigerator magnet, which is placed on the foot or toe to record curves reflecting the state of the arterial network. It does not require direct skin contact.

Group Type EXPERIMENTAL

Evaluation by magnetic sensor

Intervention Type DEVICE

Evaluation by magnetic sensor on arm and leg

Interventions

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Evaluation by magnetic sensor

Evaluation by magnetic sensor on arm and leg

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients hospitalized in the Heart-Lung Unit of the Montpellier University Hospital, for any reason whatsoever
* Patient with lower extremity artery disease (LEAD) (stage 1 to 4 according to Leriche and Fontaine) or not (absence of LEAD)
* Age ≥ 18 years

Exclusion Criteria

* Patient with a metal implant in the vicinity of the device's area of use
* Patient requiring additional hygiene precautions
* Subject not affiliated to a social security scheme or not benefiting from such a scheme.
* Pregnant or breast-feeding woman, patient unable to give consent, protected adult, vulnerable persons
* Subject deprived of liberty by judicial or administrative decision
* Patient refusing to give consent

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No