Lesion Detection of Automated Breast Ultrasound Compared With Handheld Physician-performed Breast Ultrasound

NCT02310776 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 501

Last updated 2016-02-09

Study results available
· View outcomes & findings →

Summary

Compare lesion detection of the automated breast ultrasound (ABVS) exam with the conventional handheld (HH) breast ultrasound (US) exam.

Conditions

  • Breast Diseases

Interventions

DEVICE

Supine automated breast ultrasound scanner

Automated wide-field-of-view breast ultrasound volume scan performed by a sonographer and interpreted by a breast imaging radiologist.

DEVICE

High-resolution handheld breast ultrasound

Standard of care, small field-of-view 2D breast ultrasound performed and interpreted by a breast imaging radiologist

Sponsors & Collaborators

Principal Investigators

  • Ellen B Mendelson, MD · Northwestern University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2014-03-31
Completion
2015-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT02310776 on ClinicalTrials.gov