Testing a new magnetic sensor for measuring blood flow in leg arteries
Validation Study of a Magnetic Sensor in Arterial Flow Recording, Compared With the Reference Method (Echodoppler), at Various Peripheral Arterial Sites
This study is testing a new magnetic sensor to see if it can measure blood flow in the leg arteries of patients with lower extremity artery disease better than traditional methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT06274697 on ClinicalTrials.gov |
What this trial studies
This study evaluates a prototype magnetic sensor designed to measure arterial flow in patients with lower extremity artery disease. The sensor detects weak magnetic currents generated by blood flow, aiming to provide a non-invasive and cost-effective alternative to traditional Doppler ultrasound methods. Patients hospitalized in the Heart-Lung Unit of Montpellier University Hospital will be assessed for their eligibility based on specific criteria. The goal is to validate the sensor's effectiveness compared to established methods.
Who should consider this trial
Good fit: Ideal candidates include hospitalized patients aged 18 and older with lower extremity artery disease or those without it.
Not a fit: Patients with metal implants near the sensor's area of use or those requiring additional hygiene precautions may not benefit from this study.
Why it matters
Potential benefit: If successful, this could offer a new, accessible diagnostic tool for screening peripheral arterial disease.
How similar studies have performed: While similar technologies have been explored in cardiac applications, this specific use in peripheral circulation is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Montpellier
- University Hospital Center — Montpellier, France (Recruiting)
Study contacts
- Study coordinator: Gudrun Boge, MD
- Email: g-boge@chu-montpellier.fr
- Phone: +33467336279
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.