NCT05300464

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Umbria Bioengineering Technologies · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Clinical 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.

Timeline

• Start date: 2023-01-07
• Primary completion: 2026-09-30
• Completion: 2027-01-31
• First posted: 2022-03-29
• Last updated: 2025-01-06

Locations

3 sites across 2 countries: Italy, Spain