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.
Study Type
OBSERVATIONAL
Enrollment
240
3 dimensional breast mammography system
3 dimensional breast mammography system
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
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.