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Study to compare the prototype tomosynthesis mammography system to the tomosynthesis system slated for commercial release.
A perspective non randomized, noncontrolled, multicenter pilot study enrolling a minimum of 60 female subjects. The purpose of the pilot study is to compare the images acquired from two Hologic tomosynthesis systems. Information obtained from the study will be used to determine endpoints for a future larger study. Study participants are enrolled in one of three groups, the group in which they are enrolled wil determine which tomosynthesis system images will be acquired upon.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3D investigational imaging | Patients enrolled will be imaged with a 3D mammogram in one of 3 speeds of acquisition |
| |
| 3D Imaging with commercial Mammography Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genesis and Gemini | Device | 3 dimensional breast mammography system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pilot study- To Evaluate the images acquired on 2 prototype systems for a larger study design | images are acquired on 2 systems with different speeds of time and reviewed compared to 2D images. Subjects are enrolled in one group or another and are diagnostic patients returning for addition work up on an area of interest | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Female who are undergoing screening mammography.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Investigational 3D Mammography system | Device | 3 dimensional breast mammography system |
|
| D017437 |
| Skin and Connective Tissue Diseases |