A Clinical Investigation to Confirm the Ability of MammoWave in Breast Lesions Detection

NARecruitingINTERVENTIONAL
Enrollment

600

Participants

Timeline

Start Date

January 7, 2023

Primary Completion Date

September 30, 2026

Study Completion Date

January 31, 2027

Conditions
Breast Cancer
Interventions
DEVICE

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.

Trial Locations (3)

16132

RECRUITING

IRCCS Policlinico San Martino, Genova

45007

RECRUITING

Hospital Universitario de Toledo, Toledo

06034

NOT_YET_RECRUITING

Ospedale San Giovanni Battista - USL Umbria 2, Foligno

All Listed Sponsors
lead

Umbria Bioengineering Technologies

INDUSTRY