A Post-Market Clinical Trial to Evaluate the Performance and Operation of the Brevera Breast Biopsy System

Completed

Brief Summary: The Brevera Breast Biopsy System integrates tissue acquisition, real time imaging, and post biopsy handling all during the same procedure. This post-market clinical trial will be performed to obtain clinical/operational data and feedback on the Brevera Breast Biopsy System as compared to the current standard-of-care breast biopsy procedures

Recruitment & Eligibility

Inclusion Criteria

Female aged 18 years of age or older
Subject has at least one breast imaging finding requiring biopsy for which images are available
Subject is able to understand, read and sign the trial specific informed consent form after the nature of the trial has been fully explained to her

Exclusion Criteria

Patients who, based on the physician's judgment, may be at increased risk or develop complications associated with core removal or biopsy.
Patients receiving anticoagulant therapy or may have bleeding disorders which may put the patient at increased risk of procedural complications based upon physicians judgment.

Arm && Interventions

Group	Intervention	Description
Standard of Care	Breast Biopsy	Each of the participating sites will currently be using a vacuum assisted breast biopsy system along with a specimen radiography system (or other specimen imaging system).
Brevera Breast Biopsy System	Breast Biopsy	The Brevera Breast Biopsy System with CorLumina imaging technology is a vacuum-assisted biopsy device, which is used to remove breast tissue in a minimally invasive manner using stereotactic or tomosynthesis imaging.

Primary Outcome Measures

Name	Time	Method
Difference in Procedural Time in Minutes	Average Time- Procedure (1 Lesion per subject): Total Time elapsed from when the subject enters the procedure room until they have left the procedure room, an average of 43 minutes.	The primary endpoint of this trial is the measured difference in procedure time between biopsies performed with the Brevera biopsy system and those performed with the standard-of-care biopsy systems at each clinical site. Additionally, feedback from the perspective of the participant radiologists, technologists, and subjects using the systems was reported.

Secondary Outcome Measures

Name	Time	Method
Post-biopsy Complication Rates	The time of consent until the subject procedure was completed, an average of 1 day	Adverse event percentage rates.
Number of Samples Collected Per Lesion	Samples collected from day of Breast Biopsy Procedure Only	Number of samples collected per lesion
Percentage of Procedures With Overall Positive Opinion From Radiologists, Technologists and Patients	Through study completion, enrollment expected to take up to 6-10 months at each participant site. Data collected from day of Breast Biopsy Procedure Only	The radiologists, technologists, and patients participating in this study were asked to provide feedback on the Brevera Biopsy System at the completion of each procedure. Their responses (raw scores) were reported and converted to percentage of procedures with overall positive opinion. The scale goes from 0% (poor/negative opinion) to 100% (excellent/positive opinion).

Locations (7): Washington University
🇺🇸
Saint Louis, Missouri, United States
Kensington Medical Center - Kaiser Permanente
🇺🇸
Kensington, Maryland, United States
Magee-Womens Hospital of UPMC
🇺🇸
Pittsburgh, Pennsylvania, United States
Elizabeth Wende Breast Center
🇺🇸
Rochester, New York, United States
University of Utah - Huntsman Cancer Hospital
🇺🇸
Salt Lake City, Utah, United States
HonorHealth
🇺🇸
Phoenix, Arizona, United States
MD Anderson Cancer Center
🇺🇸
Houston, Texas, United States