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

University Hospital Center (CHU)

Status: Enrolling

Conditions: Lower Extremity Artery Disease

Treatments: Device: Evaluation by magnetic sensor

Study type: Interventional

Funder types: Other

Identifiers

NCT06274697

RECHMPL22_0391

2023-A01784-41 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

Magnetic sensor

Experimental group

Description:

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.

Treatment:

Device: Evaluation by magnetic sensor