Trials / Completed
CompletedNCT01885143
A Case Collection Study for Digital Breast Tomosynthesis (DBT) Using the Senographe Essential
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 80 (actual)
- Sponsor
- GE Healthcare · Industry
- Sex
- Female
- Age
- 40 Years
- Healthy volunteers
- Not accepted
Summary
Collect clinical images requested by FDA with GE Breast Tomosynthesis to show they are of acceptable quality as defined in the relevant FDA guidance document before and after artifact correction and in standard screening images. Lossy compression will also be evaluated to demonstrate that images are of acceptable quality when lossy compression is enabled.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | Digital Breast Tomosynthesis |
Timeline
- Start date
- 2013-08-01
- Primary completion
- 2013-10-01
- Completion
- 2014-06-01
- First posted
- 2013-06-24
- Last updated
- 2014-12-02
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01885143. Inclusion in this directory is not an endorsement.