Clinical trial · Observational
Evaluation of Carebot AI MMG Medical Device for Breast Lesion Detection and Density Assessment
Evaluation of Carebot AI MMG Medical Device for Detection and Radiographic Assessment of Breast Lesions and Quantitative Analysis of Breast Density: A Multicentric, Multi-Reader Study
NCT06428799CI-TRIAL-00105851EMBLEDDA-MMGcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Tumor Benign | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carebot AI MMG | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Retrospective collection of DICOM patient files for Site 1
- description
- A total of 60 mammographic studies were retrospectively collected from Site 1 (EUC Mamocentrum Brno). The acquisition of mammography studies from Site 1 was enabled by the contract for the transfer of mammography images for medical research purposes, signed on 14 January 2022.
- interventionNames
- Device: Carebot AI MMG
- label
- Retrospective collection of DICOM patient files for Site 2
- description
- A total of 28 mammographic studies were retrospectively collected from Site 2 (Hospital Šumperk, a.s.). The acquisition of mammography studies from Institution 2 was enabled by the contract for the transfer of mammography images for medical research purposes, signed on 31 January 2023.
- interventionNames
- Device: Carebot AI MMG
- label
- Retrospective collection of DICOM patient files for Site 3
- description
- A total of 34 mammographic studies were retrospectively collected from Site 3 (Masaryk Memorial Cancer Institute). The acquisition of mammography studies from Institution 3 was enabled by the amendment to the contract for the transfer of X-ray images for medical research purposes, signed on 21 February 2023, which follows the contract for the transfer of X-ray images for medical research purposes, signed on 3 January 2022.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * The medical device is intended for use in women over 18 years of age who are indicated for screening mammography using digital mammography. Exclusion Criteria: * The medical device cannot be used in patients with breast implants. * The medical device cannot be used in male breast examination. * The medical device cannot be used in patients under 18 years of age.
References
Publications (0)
Data not yet available
No reference posted for this study.