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Successfully obtained sufficient data to complete this research project.
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The purpose of this study is to demonstrate that BVN G-1000 can precisely and consistently measure the position of female breast lesions regardless of patient rotation and probe angle during ultrasound examination.
The proposed research consists of quantitatively detecting and reporting the effect of body rotation and ultrasound probe position on the breast on the position of breast lesions relative to the breast nipple and body orientation planes, required for positional annotations, in female subjects at one study visit. Measurements will be manually and automatically recorded by two ultrasound operators with each image and will be compared among these conditions to detect effects of probe position and probe orientation and patient's body position relative to the exam table. The manual and automated measurements will be compared to determine the differences between the data obtained using the two different methods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| female breast ultrasound exam | females with at least one benign or probably benign mass, up to 2 cm in size, in one breast, detected during a standard-of-care breast ultrasound examination |
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| Measure | Description | Time Frame |
|---|---|---|
| movement of a given ultrasound breast lesion | movement of a given ultrasound breast lesion between different operators and between different body rotation positions and probe positions and orientations | study completion, an average of 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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Females of any ethnic group who meet all inclusion and none of the exclusion criteria will be eligible for enrollment
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evanston Hospital | Evanston | Illinois | 60201 | United States |
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| ID | Term |
|---|---|
| D001941 | Breast Diseases |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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