CompletedNot Applicable

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

Czechia122 participantsStarted 2022-01-14

Plain-language 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)

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Performance Test

Timeframe: 2024

Trial details

NCT IDNCT06428799

SponsorCarebot s.r.o.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-04-24

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