Discomfort Assessment of Senographe Pristina Patient-assisted Versus Standard Compression Mode and Quality Assessment of Screening Mammograms

NAUnknownINTERVENTIONAL
Enrollment

500

Participants

Timeline

Start Date

December 1, 2017

Primary Completion Date

December 1, 2020

Study Completion Date

December 1, 2020

Conditions
Mammography Related Discomfort
Interventions
DEVICE

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.

DEVICE

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."

Trial Locations (1)

08003

RECRUITING

Hospital del Mar - Parc de Salut Mar, Barcelona

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GE Healthcare

INDUSTRY

lead

Parc de Salut Mar

OTHER

NCT03928886 - Discomfort Assessment of Senographe Pristina Patient-assisted Versus Standard Compression Mode and Quality Assessment of Screening Mammograms | Biotech Hunter | Biotech Hunter