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 range

18 Years

Sex

FEMALE

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Performance Test

Timeframe: 2024

Trial details

NCT IDNCT06428799

SponsorCarebot s.r.o.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-04-24

View on ClinicalTrials.gov More Breast Cancer trials