Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06428799
Status:
COMPLETED
Last Update Posted:
2024-05-24
First Post:
2024-05-07
Brief Title:
Evaluation of Carebot AI MMG Medical Device for Breast Lesion Detection and Density Assessment
Sponsor:
Carebot sro
Organization:
Carebot sro
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMBLEDDA-MMG
Brief Summary:
Comparison of accuracy of clinician and DLAD image evaluation Carebot AI MMG v22
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
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
Detailed Description:
The mammography studies were acquired from three independent sites Site 1 EUC Mamocentrum Brno and Site 2 Hospital Šumperk as specialise in routine screening mammography and Site 3 Masaryk Memorial Cancer Institute is a comprehensive oncology facility primarily dedicated to diagnostic mammography ie performing additional examinations in case of a suspicious finding recall
The ground truth was obtained by consensus of two board-certified radiologists with expertise in radiology and diagnostic methods and 13 and 27 years of experience with mammography image interpretation respectively
For comparative analysis a team of five independent radiologists with clinical experience in interpreting mammography images was established Three of the clinicians were junior 2 2 and 4 years of experience respectively without board-certification two physicians were senior 7 and 8 years of experience respectively board-certified
The ground truth was obtained by consensus of two board-certified radiologists with expertise in radiology and diagnostic methods and 13 and 27 years of experience with mammography image interpretation respectively
For comparative analysis a team of five independent radiologists with clinical experience in interpreting mammography images was established Three of the clinicians were junior 2 2 and 4 years of experience respectively without board-certification two physicians were senior 7 and 8 years of experience respectively board-certified
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None