A Clinical Investigation to Confirm the Ability of MammoWave in Breast Lesions Detection
Recruiting · NCT05300464 · Interventional (participants receive a specific treatment) · Lead sponsor: Umbria Bioengineering Technologies
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is 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.
Who can take part
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
Where it is running
4 locations listed.
- Az. San. Univ. Giuliano Isontina (ASU GI) - Trieste, Italy
- IRCCS Policlinico San Martino - Genova, Genova, Italy
- Ospedale San Giovanni Battista - USL Umbria 2 - Foligno, Perugia, Italy
- Hospital Universitario de Toledo - Toledo, Spain, Spain