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Recruiting Not applicable

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

NCT06274697 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2024-04-02
Last updated
2024-11-25

Condition(s) studied

Lower Extremity Artery Disease

Investigational drug(s) / intervention(s)

Evaluation by magnetic sensor

Evaluation by magnetic sensor: Evaluation by magnetic sensor on arm and leg

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Correlation of the two curve amplitudes (y) versus time (x) between the signal recording obtained by the CapMagic prototype on the radial artery and the pulsed echo-Doppler recording on the radial artery — On day 1
    Correlation of the two curve amplitudes (y) versus time (x) between the signal recording obtained by the CapMagic prototype on the radial artery and the pulsed echo-Doppler recording on the radial artery, in adult patients with or without AOMI in hospital. The result is expressed by a Spearman correlation coefficient ranging from -1 to 1, with 0 corresponding to no correlation and 1 corresponding to a perfect positive correlation

Trial sites (1)

FacilityCityRegionStatus
University Hospital Center Montpellier France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06274697 on ClinicalTrials.gov ↗ ← All trials in France