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Clinical Trial Details — Status: Terminated

Administrative data

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

Study information

Verified date July 2021
Source MetriTrack, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Evanston Hospital Evanston Illinois

Sponsors (1)

Lead Sponsor Collaborator
MetriTrack, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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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