500
Participants
Start Date
December 1, 2017
Primary Completion Date
December 1, 2020
Study Completion Date
December 1, 2020
bilateral two-view (CC and MLO) FFDM (full field digital mammography) using patient-assisted compression mode
Patient-assisted mode of Senographe Pristina (a commercial mammography medical device consisting of the Senographe Pristina FFDM system -2D- and Senographe Pristina DBT option -3D-) for FFDM imaging procedure. The patient-assisted compression feature enables the patient to personally refine breast compression using a hand-held remote control after the compression has been initiated by the operator, which is required to ensure proper breast positioning.
bilateral two-view (CC and MLO) FFDM (full field digital mammography) using standard compression mode
"Standard compression mode of Senographe Pristina (a commercial mammography medical device consisting of the Senographe Pristina FFDM system -2D- and Senographe Pristina DBT option -3D-) for FFDM imaging procedure.~Study-related compressions will consist of the first and second CC and MLO compressions performed on each breast during each subject's exam."
RECRUITING
Hospital del Mar - Parc de Salut Mar, Barcelona
Collaborators (1)
GE Healthcare
INDUSTRY
Parc de Salut Mar
OTHER