A Clinical Investigation to Evaluate Microwave Imaging Via MammoWave® in a Population-based Screening Program for Early Breast Cancer Detection
Recruiting
N/A
Interventional Study
Women's Health: Neoplasm of Breast
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 45 – 74
- Sex
- Female
- Study type
- Interventional
- Purpose
- Screening
- Participants needed
- 10,000 (estimated)
- Sponsor
- Umbria Bioengineering Technologies · Industry
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About This Trial
This is an open, multicentric, interventional, prospective, non-randomized clinical investigation. The first aim of the study is to confirm that MammoWave reaches sensitivity\>75% and specificity\>90% in breast cancer (BC) detection on 10.000 volunteers undergoing regular screening programs.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Women aged between 45 and 74 years
* Asymptomatic
* Signed informed consent form before starting any study activity
* Average risk of BC (every woman except those with know BRCA1, 2, TP53, and/or previous BC)
* Mammographic test, either 2D FFDM or 3D Digital Breast Tomosynthes…
Contacts