A Clinical Investigation to Evaluate Microwave Imaging Via MammoWave® in a Population-based Screening Program for Early Breast Cancer Detection

NARecruitingINTERVENTIONAL
Enrollment

10,000

Participants

Timeline

Start Date

March 15, 2024

Primary Completion Date

February 15, 2026

Study Completion Date

December 15, 2026

Conditions
Women's Health: Neoplasm of Breast
Interventions
DEVICE

MammoWave

"Women undergoing conventional breast screening examination will be asked by the clinical staff if they are interested in taking part in the study.~A short visit should be performed to check the inclusion/exclusion criteria, review demographic data, and the volunteer's medical history. After performing this visit, the volunteers will perform the MammoWave exam on both their breasts.~The exam will be composed of two phases: data acquisition and data processing. During the acquisition, which should take about 8 minutes, the volunteers would be lying down in a prone position, on the bed which is part of MammoWave.~When the acquisition is completed, the data will be processed through a dedicated microwave imaging algorithm. The output will be composed of microwave images, plus parameters describing the images. MammoWave output will also comprise a label obtained using an optimized classification algorithm."

Trial Locations (9)

16132

RECRUITING

IRCCS Policlinico San Martino, Genova

06034

RECRUITING

Ospedale San Giovanni Battista - USL Umbria 2, Foligno

Unknown

RECRUITING

Pomeranian Medical University Hospital, Szczecin

RECRUITING

Champalimaud Foundation, Lisbon

RECRUITING

Clínica Dr. Passos Ângelo in Lisbon, Lisbon

RECRUITING

Hospital Universitario Reina Sofía- Córdoba, Córdoba

NOT_YET_RECRUITING

Hospital General Universitario Morales Meseguer, Murcia

RECRUITING

Complejo Hospitalario Universitario de Toledo, Toledo

RECRUITING

Diagnostic and Interventional Radiology, University Hospital Zurich, Zurich

All Listed Sponsors
collaborator

London South Bank University

OTHER

collaborator

ELAROS 24/7 Limited (UK)

UNKNOWN

collaborator

Servicio De Salud De Castilla La Mancha (Spain)

UNKNOWN

collaborator

IMT School for Advanced Studies Lucca

OTHER

collaborator

EVITA - Cancro Hereditário (Portugal)

UNKNOWN

collaborator

Fondazione Toscana Life Sciences (Italy)

UNKNOWN

lead

Umbria Bioengineering Technologies

INDUSTRY