An Evaluation of a Self-contained Direct Digital Radiography System for Breast Specimen Imaging

NAUnknownINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

June 30, 2012

Study Completion Date

June 30, 2012

Conditions
Breast Cancer
Interventions
DEVICE

Trident Specimen Radiography System

MIBB images will be acquired on the standard of care device and the Trident System in the Breast Center at Hoag Hospital. BSS images will be acquired on standard of care device in the Operating Room and/or the Breast Center at Hoag Hospital and then on the Trident System. Image quality will be compared and system operation will be evaluated. Feedback will be provided to manufacturer and the Trident System further refined.

DEVICE

Bioptics, Faxitron, and Full Field Digital Mammography (FFDM) Selenia

All the above devices are used for SOC BSS imaging at Hoag Hospital. The images captured from these devices will be compared to the images captured from the Trident Specimen Radiography device.

Trial Locations (1)

92658

RECRUITING

Hoag Memorial Hospital Presbyterian, Newport Beach

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Hologic, Inc.

INDUSTRY

lead

Levine, Gary M. , M.D.

INDIV