Actively Recruiting
A Clinical Investigation to Confirm the Ability of MammoWave in Breast Lesions Detection
Led by Umbria Bioengineering Technologies · Updated on 2025-01-06
600
Participants Needed
3
Research Sites
212 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
A Clinical Investigation to Confirm the Ability of MammoWave in Breast Lesions Detection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed Informed consent Form
- Women
- Adult 63 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
IRCCS Policlinico San Martino
Genova, Genova, Italy, 16132
Actively Recruiting
2
Ospedale San Giovanni Battista - USL Umbria 2
Foligno, Perugia, Italy, 06034
Not Yet Recruiting
3
Hospital Universitario de Toledo
Toledo, Spain, Spain, 45007
Actively Recruiting
Research Team
G
Gianluigi Tiberi
CONTACT
S
Sabatino Tiberi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
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