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

Hologic

Status: Completed

Conditions: Breast Cancer Female

Treatments: Device: Breast Biopsy

Study type: Observational

Funder types: Industry

Identifiers

NCT03300206

16-05B

Details and patient eligibility

About

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

Enrollment: 525 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

525 participants in 2 patient groups

Brevera Breast Biopsy System

Description:

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.

Treatment:

Device: Breast Biopsy

Standard of Care

Description:

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).

Treatment:

Device: Breast Biopsy