Trials / Completed
CompletedNCT05615298
Study to Evaluate Effectiveness of Investigational Device in the Assistance of Detection and Diagnosis of Breast Cancer
Multi-reader, Multi-case, Observer-blind, Retrospective, Pivotal Study to Evaluate Effectiveness of Investigational Device in the Assistance of Detection and Diagnosis of Breast Cancer During Screening Mammography Interpretation
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 240 (actual)
- Sponsor
- Lunit Inc. · Industry
- Sex
- Female
- Age
- —
- Healthy volunteers
- Accepted
Summary
This study aims to evaluate Effectiveness of Investigational Device, Lunit INSIGHT MMG, in the assistance of Detection and Diagnosis of Breast Cancer during Screening Mammography Interpretation.
Detailed description
The Lunit INSIGHT MMG is developed as a computer-assisted detection/diagnosis device based on deep learning technology. In this pivotal study, effectiveness of the investigational device, Lunit INSIGHT MMG, was examined by comparing the reading panelist's interpretation ability between CAD assisted and unassisted during screening mammography interpretation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | Mammography | FFDM (Full-Field Digital mammography) |
Timeline
- Start date
- 2020-06-15
- Primary completion
- 2021-01-13
- Completion
- 2021-01-13
- First posted
- 2022-11-14
- Last updated
- 2022-11-14
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05615298. Inclusion in this directory is not an endorsement.