Effect of Body Position and Probe Position on the Localization of Breast Mass

NCT ID: NCT02997540

Last Updated: 2021-07-21

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2020-01-31

Brief 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.

Detailed 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.

Conditions

Breast Diseases

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

MetriTrack, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Evanston Hospital

Evanston, Illinois, United States

Countries

United States

Other Identifiers

BVN G-1000

Identifier Type: -

Identifier Source: org_study_id