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

Study Overview
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Brief Summary
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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

Official Title
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A Prospective, Block Stratified Clinical Trial to Evaluate the Performance and Operation of the Brevera Breast Biopsy System

Conditions
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Breast Cancer Female

Intervention / Treatment
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* Device: Breast Biopsy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Brevera Breast Biopsy System<br>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. | Device: Breast Biopsy<br>* A breast biopsy is a test that removes tissue or sometimes fluid from the suspicious area. The removed cells are examined under a microscope and further tested to check for the presence of breast cancer. A biopsy is a diagnostic procedure that can definitely determine if the suspicious area is cancerous.<br>|
| Standard of Care<br>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). | Device: Breast Biopsy<br>* A breast biopsy is a test that removes tissue or sometimes fluid from the suspicious area. The removed cells are examined under a microscope and further tested to check for the presence of breast cancer. A biopsy is a diagnostic procedure that can definitely determine if the suspicious area is cancerous.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Time | The primary endpoint of this trial is the measured difference in procedure time between biopsies performed with the Brevera biopsy system with real time imaging and biopsies performed using the standard-of-care biopsy system at each clinical site. | Through study completion - Data collected from day of Breast Biopsy Procedure Only | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-biopsy complication rates | Adverse event rates. | Through study completion - Data collected from day of Breast Biopsy Procedure Only | 
| Total tissue acquisition by number of cores and sample mass, | Tissue weight and number of cores collected | Through study completion - Data collected from day of Breast Biopsy Procedure Only | 
| Feedback from Radiologist, Technologist and Patient | Questionnaire Feedback | Through study completion - Data collected from day of Breast Biopsy Procedure Only | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Biopsy, Breast Biopsy Imaging, Stereotactic Biopsy