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

Hologic, Inc.525 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

525

Conditions

Breast Cancer Female

Interventions

Breast BiopsyDEVICE

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (7)

HonorHealth

Phoenix, Arizona, United States

Kensington Medical Center - Kaiser Permanente

Kensington, Maryland, United States

Washington University

St Louis, Missouri, United States

Elizabeth Wende Breast Center

Rochester, New York, United States

Outcomes

Primary Outcomes

Difference in Procedural Time in Minutes

The primary endpoint of this trial is the measured difference in procedure time between biopsies performed with the Brevera biopsy system and those performed with the standard-of-care biopsy systems at each clinical site. Additionally, feedback from the perspective of the participant radiologists, technologists, and subjects using the systems was reported.

Time frame: Average Time- Procedure (1 Lesion per subject): Total Time elapsed from when the subject enters the procedure room until they have left the procedure room, an average of 43 minutes.

Secondary Outcomes

Post-biopsy Complication Rates

Adverse event percentage rates.

Time frame: The time of consent until the subject procedure was completed, an average of 1 day

Number of Samples Collected Per Lesion

Number of samples collected per lesion

Time frame: Samples collected from day of Breast Biopsy Procedure Only

Percentage of Procedures With Overall Positive Opinion From Radiologists, Technologists and Patients

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 opinion. The scale goes from 0% (poor/negative opinion) to 100% (excellent/positive opinion).

Time frame: Through study completion, enrollment expected to take up to 6-10 months at each participant site. Data collected from day of Breast Biopsy Procedure Only

Data from ClinicalTrials.gov

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