N/A
N=501
Lesion Detection of Automated Breast Ultrasound Compared With Handheld Physician-performed Breast Ultrasound
Breast Diseases
Bottom Line
View on ClinicalTrials.gov: NCT02310776 ↗Enrolled (actual)
501
Serious AEs
0.0%
Results posted
May 2015
Primary outcome: Primary: Ratio of Lesions Detected With Automated Breast Ultrasound (ABVS) Compared to the Standard of Care Handheld (HH) Breast Ultrasound (US) — 1.19 Detection ratio of lesions
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Supine automated breast ultrasound scanner (Device); High-resolution handheld breast ultrasound (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ratio of Lesions Detected With Automated Breast Ultrasound (ABVS) Compared to the Standard of Care Handheld (HH) Breast Ultrasound (US) |
1.19 | — |
Summary
Compare lesion detection of the automated breast ultrasound (ABVS) exam with the conventional handheld (HH) breast ultrasound (US) exam.
Eligibility Criteria
Inclusion Criteria
- anyone who is referred for an ultrasound of the breast
Exclusion Criteria
- Subjects whose breast thickness is greater than 6 cm.The maximum depth of image filed for the ABVS acquisition is 6 cm
Data sourced from ClinicalTrials.gov (NCT02310776). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.