Trials / Completed
CompletedNCT02692209
A Multi-Reader Multi-Case Pivotal Trial
A Multi-Reader Multi-Case Controlled Clinical Trial to Evaluate the Comparative Accuracy of the Fujifilm FFDM Plus DBT Versus FFDM Alone in the Detection of Breast Cancer
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 298 (actual)
- Sponsor
- Fujifilm Medical Systems USA, Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this pivotal reader study is to assess the comparative accuracy of Fujifilm FFDM plus DBT versus FFDM alone in the detection of breast cancer.
Detailed description
The safety and effectiveness of FFDM + DBT are both linked to the ability of radiologists interpreting FFDM + DBT images to accurately diagnose breast cancer. Each study endpoint therefore addresses both safety and effectiveness.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | FFDM Plus DBT | FFDM + DBT Images FujiFilm Aspire Cristalle System |
| DEVICE | FFDM Alone | FFDM Alone Images |
Timeline
- Start date
- 2015-12-01
- Primary completion
- 2016-01-01
- Completion
- 2016-01-01
- First posted
- 2016-02-25
- Last updated
- 2020-07-07
- Results posted
- 2020-06-11
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02692209. Inclusion in this directory is not an endorsement.