Evaluation of Carebot AI MMG Medical Device for Breast Lesion Detection and Density Assessment

CompletedOBSERVATIONAL
Enrollment

122

Participants

Timeline

Start Date

January 14, 2022

Primary Completion Date

April 24, 2024

Study Completion Date

April 24, 2024

Conditions
Breast CancerBreast Tumor Benign
Interventions
DEVICE

Carebot AI MMG

"Carebot AI MMG is a software solution that utilizes artificial intelligence methods, specifically deep learning and computer vision algorithms, to evaluate and localize suspicious regions of potential lesions during the interpretation of digital breast x-rays as part of standard mammography screening procedures. The Carebot AI MMG medical device is not intended for use in diagnostic mammography. The Carebot AI MMG is intended for use in women over the age of 18.~The predictive outputs of the Carebot AI MMG medical device are intended to aid decision-making in screening clinical practice, always in conjunction with other relevant patient information and based on the professional judgment of the examining clinician. The Carebot AI MMG is specifically designed to provide a supporting layer of analysis that helps in evaluating or prioritizing mammography images with additional patient information and the professional judgment of the examining physician."

Trial Locations (3)

60200

EUC Mamocentrum Brno, Brno

Masaryk Memorial Cancer Institute, Brno

78701

Hospital Šumperk, Šumperk

All Listed Sponsors
lead

Carebot s.r.o.

INDUSTRY