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

NCT06428799 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 122

Last updated 2026-03-18

No results posted yet for this study

Summary

Comparison of accuracy of clinician and DLAD image evaluation (Carebot AI MMG v2.2)

1. Comparison of the Accuracy of Density Assessment by Clinician and DLAD (DENS)
2. Comparison of Accuracy of Lesion Assessment by Clinician and DLAD (MASS, CLASS)

Conditions

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.

Sponsors & Collaborators

  • Carebot s.r.o.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-14
Primary Completion
2024-04-24
Completion
2024-04-24

Countries

  • Czechia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06428799 on ClinicalTrials.gov