Brevera™ Breast Biopsy System Data Collection Study

• Brevera Breast Biopsy System (Device): 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.

Primary outcomes

• Procedural Time [Through study completion, enrollment expected to take up to 6-10 months at each site - Data collected from day of Breast Biopsy Procedure Only]: Total time elapsed between from when the subject enters the procedure room until she has left the procedure room.

Secondary outcomes

• Post-biopsy Complication Rates [Through study completion, enrollment expected to take up to 6-10 months at each site - Data collected from day of Breast Biopsy Procedure Only]: Adverse event rates.
• Average Number of Cores Per Lesion [Through study completion, enrollment expected to take up to 6-10 months at each site - Data collected from day of Breast Biopsy Procedure Only]: The average number of cores obtained for each lesion across all sites.
• Percentage of Procedures With Overall Positive Opinion From Radiologist, Technologist, and Patient [Through study completion, enrollment expected to take up to 6-10 months at each 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 opinions. The scale goes from 0% (poor/negative opinion) to 100% (excellent/positive opinion).

Sex: Female, ages: 18 Years to any

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.

Participant flow

Outcome results

• Procedural Time (Primary), Mean, Minutes: Brevera Breast Biopsy System 38.44 +/- 14.17
• Post-biopsy Complication Rates (Secondary), Count of participants, Participants: Brevera Breast Biopsy System 11
• Average Number of Cores Per Lesion (Secondary), Mean, Cores Per Lesion: Brevera Breast Biopsy System 10.58 (2 to 48)
• Percentage of Procedures With Overall Positive Opinion From Radiologist, Technologist, and Patient (Secondary), Mean, Percentage of procedures: Radiologists' Feedback 76.3 (8.45 to 91.5); Technologists' Feedback 66.9 (10.1 to 89.9); Patients' Feedback 96.8 (0.6 to 99.4)

Adverse events

Time frame: subjects were evaluated for the time the procedure began to the release from the outpatient treatment facility per standard of care for any adverse events that they experienced.

Other adverse events by term

• Study Protocol and Statistical Analysis Plan (PDF, 2017-02-28)

• Brad Keller, Study director, Hologic, Inc.