Breast Diseases Clinical Trial
Official title:
Evaluation of the Effect of Body Position and Probe Position on the Localization of Breast Mass in Free-Hand Breast Ultrasound Examination
NCT number | NCT02997540 |
Other study ID # | BVN G-1000 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | November 2016 |
Est. completion date | January 2020 |
Verified date | July 2021 |
Source | MetriTrack, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 20 |
Est. completion date | January 2020 |
Est. primary completion date | January 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 21 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. Female 2. 21-70 years of age 3. Known palpable or non-palpable benign or probably benign breast mass or masses, less than 2 cm in maximum diameter and at least 4 cm away from the nipple, from a previous ultrasound examination Exclusion Criteria: 1. Women with cardiac pacemaker or portable defibrillator 2. Women with known breast cancer or suspicious lesions 3. Pregnant and lactating women 4. Women who have breast implant(s) 5. Women who have had prior breast surgical intervention not including breast needle biopsy, in the same breast with the qualifying target mass. 6. Women with the target finding to be mapped within a distance of 4 cm from patient's nipple. 7. Women with multiple similar qualifying targets in close proximity (less than 4 cm between targets). 8. Women with history of allergy to medical-grade adhesive tape or ultrasound gel 9. Women whose weight is over 250 pounds |
Country | Name | City | State |
---|---|---|---|
United States | Evanston Hospital | Evanston | Illinois |
Lead Sponsor | Collaborator |
---|---|
MetriTrack, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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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