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

Status:	Recruiting
Conditions:	Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	2/23/2019
Start Date:	September 13, 2017
End Date:	March 31, 2019
Contact:	Brian Sundell, MS
Email:	Brian.Sundell@Hologic.com
Phone:	781-999-7515

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

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

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.

We found this trial at

sites

Washington University

Saint Louis, Missouri 63110

Phone: 314-799-6772

from

Saint Louis, MO