Status:
RECRUITING
A Clinical Investigation to Confirm the Ability of MammoWave in Breast Lesions Detection
Lead Sponsor:
Umbria Bioengineering Technologies
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 ...
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 e...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2027
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT05300464
Start Date
January 7 2023
End Date
January 31 2027
Last Update
January 6 2025
Active Locations (3)
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1
IRCCS Policlinico San Martino
Genova, Genova, Italy, 16132
2
Ospedale San Giovanni Battista - USL Umbria 2
Foligno, Perugia, Italy, 06034
3
Hospital Universitario de Toledo
Toledo, Spain, Spain, 45007