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

NCT01379092 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2012-03-16

No results posted yet for this study

Summary

The objective of this study is to evaluate the image quality and operation of a self-contained direct digital radiography system for breast specimen imaging.

Conditions

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.

Sponsors & Collaborators

  • Hologic, Inc.

    collaborator INDUSTRY

  • Levine, Gary M. , M.D.

    lead INDIV

Principal Investigators

  • Gary M. Levine, M.D. · Hoag Memorial Hospital Presbyterian

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01379092 on ClinicalTrials.gov