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Comparison of the Philips MicroDose Tomosynthesis System to 2D Digital Mammography

NCT02615509 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 347

Last updated 2020-05-08

Study results available
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Summary

The primary objective of this study is to compare the safety and clinical performance of the Philips MicroDose Tomosynthesis system images and images from FFDM systems.

Conditions

Interventions

RADIATION

Imaging on experimental tomo device

The system used for imaging in the experimental arm is the Philips MicroDose tomography system. The system used for imaging in the active comparator is a standard FFDM system

Sponsors & Collaborators

  • Philips Digital Mammography Sweden AB

    lead INDUSTRY

Principal Investigators

  • Etta Pisano, PhD · Beth Israel Deaconess Medical Center

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2018-02-20
Completion
2018-02-20

Countries

  • United States

Study Locations

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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 NCT02615509 on ClinicalTrials.gov