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
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
-
Siemens Medical Solutions
collaborator INDUSTRY - lead OTHER
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
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