600
Participants
Start Date
January 7, 2023
Primary Completion Date
September 30, 2026
Study Completion Date
January 31, 2027
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.
RECRUITING
IRCCS Policlinico San Martino, Genova
RECRUITING
Hospital Universitario de Toledo, Toledo
NOT_YET_RECRUITING
Ospedale San Giovanni Battista - USL Umbria 2, Foligno
Umbria Bioengineering Technologies
INDUSTRY