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Breast Neoplasms

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. 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.

Brevera Breast Biopsy System

Brad Keller

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.

Brevera™ Breast Biopsy System Data Collection Study

A Prospective Study To Evaluate The Performance And Operation Of The Brevera™ Breast Biopsy System

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.

Tissue weight and number of cores collected

Questionnaire Feedback using a Likert Scale (Pre-coded responses with the neutral point being neither agree nor disagree). The total averages will be compiled from the survey responses for marketing claims purposes.

Hologic, Inc.

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.

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).

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.

Breast Biopsy

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

Only females (biologic) will be eligible for participation in the clinical trial.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Brevera™ Breast Biopsy System Data Collection Study	NCT03456583	Breast Cancer F...	Brevera Breast ...	18 Years -	Hologic, Inc.
A Post-Market Clinical Trial to Evaluate the Performance and Operation of the Brevera Breast Biopsy System	NCT03300206	Breast Cancer F...	Breast Biopsy	18 Years -	Hologic, Inc.
A Post-Market Clinical Trial to Evaluate the Performance and Operation of the Brevera Breast Biopsy System	NCT03300206	Breast Cancer F...	Breast Biopsy	18 Years -	Hologic, Inc.

Spots Global Cancer Trial Database for breast biopsy imaging