Clinical Investigation to Evaluate the Ability of MammoWave in Breast Lesions Detection (NCT04253366) | Clinical Trial Compass
CompletedNot Applicable
Clinical Investigation to Evaluate the Ability of MammoWave in Breast Lesions Detection
Italy, Spain353 participantsStarted 2020-09-16
Plain-language summary
This is a multicentric, single arm, prospective, stratified by breast density clinical investigation using Mammowave that is a device, which uses microwaves instead of ionizing radiation (X-ray)for breast lesions(BL) detection. Specifically, Mammowave employs a novel technique which generates images by processing very low power (\<1 mW) microwaves. The exam takes few minutes per breast and is performed with the patient lying in a comfortable facing down position. Mammowave is safe to be used at any age, in any condition (pregnancy, specific illness) and for unlimited number of times.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Signed Informed consent Form
✓. Women
✓. Adult ≥18 years old
✓. Having a radiologist study output obtained using conventional exams (such as breast specialist visit and mammography and/or ultrasound and/or magnetic resonance imaging) within the last month.
✓. Patients willing to comply with study protocol and recommendations.
✓. Patients with intact breast skin (i.e. without bleeding lesion, scar).
Exclusion criteria
✕. Patients that are enrolled in another clinical study
✕. Patients who belong to any vulnerable group.
✕. Patients with implanted electronics.
✕. Patients who have undergone biopsy less than one week before MammoWave scan
✕
What they're measuring
1
MammoWave sensitivity (number of 'true positive' results)