RecruitingNot ApplicableNCT05300464

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

A Clinical Investigation (multicentric, Single Arm, Prospective, Stratified) to Confirm the Ability of MammoWave (microwave Mammogram) in Breast Lesions Detection

Sponsor

Umbria Bioengineering Technologies

Enrollment

600 participants

Start Date

Jan 7, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

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 Criteria5

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

Interventions

DEVICEClinical investigation medical device class IIa marked CE

Patients should perform MammoWave exam. A short visit should be performed and during this visit a qualitative differentiation would be performed between patients with high density breast, and patients with low density breast. After the patients are ready for MammoWave exam. The exam will composed of two phases: the acquisition and data processing. During the acquisition that sholud takes about 10 minutes the patients would be lying in a prone position, on a bed which is part of the MammoWave. The upper part of MammoWave has a container cup shape, which contains the breast, which also has the function of separate it from the internal parts of the device. After patient is on the bed and MammoWave would start to perform the acquisition. Once the acquisition is completed, the data will be processed through an imaging algorithm, which is integrated in the device. The final output will be composed by one or more images, plus one or more parameters describing the images.