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A Clinical Investigation to Confirm the Ability of MammoWave in Breast Lesions Detection

RecruitingNAAges 18 Years - anyFemaleUmbria Bioengineering Technologies
NCT05300464 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is a multicentric, single arm, prospective, stratified by breast density clinical investigation to confirm the ability of the microwave mammogram 'MammoWave' to detect breast lesions. MammoWave is a innovative medical device, class IIa marked CE, which uses microwaves instead of ionazing radiation (x-ray) for breast lesions. Specifically MammoWave employs a novel technique wich generates images by processing very low power (\<1mW) microwave. The MammoWave exam takes few minutes for breast and is performed with the patient lying in a confortable facing down position. MammoWave is safe to be used at any age, in any condition (pregnancy, specific illness and for unlimited number of times.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Signed Informed consent Form * Women * Adult ≥ 18 years old * Having a radiologist study output obtained using mammography within the last month. Such radiologist study output may be integrated with ultrasound and /or magnetic resonance imaging output if deemed necessary by the responsible investigator and when available. The radiological output will be integrated with histological one if deemed necessary by the responsible investigator and when available. * Patients willing to comply with study protocol and recommendations Exclusion Criteria: * Patients who belong to any vulnerable group * Patients with implanted electronic devices * Patients who have undergone biopsy less than one week before MammoWave scan * Patients with nipple piercings (unless they are removed prior to examination) * Pregnancy or breastfeeding
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What it tests

  • Clinical investigation medical device class IIa marked CE
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Where

4 sites
IRCCS Policlinico San Martino
Genova, Italy
Ospedale San Giovanni Battista - USL Umbria 2
Foligno, Italy
Az. San. Univ. Giuliano Isontina (ASU GI)
Trieste, Italy
Hospital Universitario de Toledo
Toledo, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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