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

NCT02997540 | Terminated

• 1 other identifier: BVN G-1000
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Diseases

Keywords

female breast lesion; ultrasound examination

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Females of any ethnic group who meet all inclusion and none of the exclusion criteria will be eligible for enrollment

You may qualify if:

• Female
• years of age
• 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

You may not qualify if:

• Women with cardiac pacemaker or portable defibrillator
• Women with known breast cancer or suspicious lesions
• Pregnant and lactating women
• Women who have breast implant(s)
• Women who have had prior breast surgical intervention not including breast needle biopsy, in the same breast with the qualifying target mass.
• Women with the target finding to be mapped within a distance of 4 cm from patient's nipple.
• Women with multiple similar qualifying targets in close proximity (less than 4 cm between targets).
• Women with history of allergy to medical-grade adhesive tape or ultrasound gel
• Women whose weight is over 250 pounds

Sponsors & Collaborators

• MetriTrack, Inc.: lead

Study Sites (1)

Evanston Hospital

Evanston, Illinois, 60201, United States

Location

MeSH Terms

Conditions

Breast Diseases

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2016
• First Posted: December 20, 2016
• Study Start: November 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: July 21, 2021

Record last verified: 2021-07

Locations

US (1)