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

Umbria Bioengineering Technologies

Status: Enrolling

Conditions: Breast Cancer

Treatments: Device: Clinical investigation medical device class IIa marked CE

Study type: Interventional

Funder types: Industry

Identifiers

NCT05300464

UBT 2022-01

Details and patient eligibility

About

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.

Full description

The maximum number of participants to the clinical investigation will be 600 (for all the sites). The study will be composed of two phases: a preliminary phase to 'optimize the imaging algorithm for each apparatus installed at each centre', where 15 volunteers (in each centre) having breast with no lesions (NL) will be examined by MammoWave. In the second phase, the remaining people will be enrolled (BL will be 50% of total) and examined by MammoWave by the clinical investigator, and results will be compared with the effective diagnosis already obtained by standard clinical methods. BL includes malignant lesions (BC) and benign lesions, and may be palpable or non-palpable lesions. BL includes also isolated clustered microcalcifications.

The primary gol of the clinical study is to assess MammoWave's ability in BL detection.

The study will involve investigational sites in Italy, Germany and Spain.

Enrollment: 600 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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600 participants in 1 patient group

Single arm

Other group

Description:

All patients perform standard breast screening and also MammoWave exam.

Treatment:

Device: Clinical investigation medical device class IIa marked CE