Ignite Creation Date:
2024-07-17 @ 11:05 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06479772
Status:
COMPLETED
Last Update Posted:
2024-06-28
First Post:
2023-12-15
Brief Title:
Evaluation of the Potential Impact of an Artificial Intelligence Solution in Second Reading of Organized Screening
Sponsor:
GCS Ramsay Santé pour lEnseignement et la Recherche
Organization:
GCS Ramsay Santé pour lEnseignement et la Recherche
Study Overview
Official Title:
Evaluation of the Potential Impact of an Artificial Intelligence Solution in Second Reading of Organized Screening
Status:
COMPLETED
Status Verified Date:
2024-06
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:
ELIAS
Brief Summary:
Based on data from a series of patients who underwent screening mammography with a normal or benign first-reading result The main objective of the study is to evaluate the possibilities of subtracting from the second reading of breast cancer screening a population of examinations for which the risk of discovering cancer is close to zero using an AI system here the MammoScreen system
Detailed Description:
This is a retrospective multicenter study of mammography imaging data contained in the PACS Picture Archiving and Communication System of six radiology centers located in the Rhône Puy de dôme Cantal and Haute-Loire départements
In order to be able to collect two-year follow-up data the files analyzed will concern all women who received a screening mammogram during the years 2015 2016 2017 2018 and 2019 More recent mammograms will be excluded
In order to be able to collect two-year follow-up data the files analyzed will concern all women who received a screening mammogram during the years 2015 2016 2017 2018 and 2019 More recent mammograms will be excluded
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