Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-31 @ 8:09 PM
Study NCT ID:
NCT05716958
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2023-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-Reader, Multi-Case, Cross-Over, Retrospective Study to Evaluate Effectiveness of Lunit INSIGHT DBT
Sponsor:
Lunit Inc.
Organization:
Study Overview
Official Title:
Multi-Reader, Multi-Case, Cross-Over, Retrospective, Superiority, Pivotal Study to Evaluate Effectiveness of Lunit INSIGHT DBT in the Assistance of Detection and Diagnosis of Breast Cancer During 3D Mammography Interpretation
Status:
COMPLETED
Status Verified Date:
2023-01
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:
None
Brief Summary:
This study aims to evaluate Effectiveness of Lunit INSIGHT DBT in the assistance of detection and diagnosis of breast cancer during 3D mammography interpretation
Detailed Description:
The primary objective of the trial is to evaluate the effectiveness of Lunit INSIGHT DBT in the assistance of detection and diagnosis of breast cancer by comparing the clinical performance of radiologists before and after using Lunit INSIGHT DBT in their DBT reading and secondarily examining the use of Lunit INSIGHT DBT to shorten DBT reading time.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: