Brevera™ Breast Biopsy System Data Collection Study

A Prospective Study 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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer Female
• Intervention / Treatment: Device: Brevera Breast Biopsy System

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• France
  • Montpellier, France
    • Institut Regional Du Cancer de Montpellier
• Germany
  • Tübingen, Germany
    • Brustdiagnostik Munchen
• Italy
  • Milan, Italy
    • Radiologia Senologica
• Netherlands
  • Alkmaar, Netherlands
    • Noordwest Ziekenhuisgroep
• Spain
  • Madrid, Spain
    • Centro de Patalogia de la Mama-Fundacion Tejerina
• United Kingdom
  • London, United Kingdom
    • Royal Free Londan NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Any woman who is scheduled for a stereotactic breast biopsy (for possible breast cancer) who meets the inclusion/exclusion criteria.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Brevera Breast Biopsy System; 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.

Device: Brevera Breast Biopsy System; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-biopsy Complication Rates	Adverse event 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
Average Number of Cores Per Lesion	The average number of cores obtained for each lesion across all sites.	Through study completion, enrollment expected to take up to 6-10 months at each site - Data collected from day of Breast Biopsy Procedure Only
Percentage of Procedures With Overall Positive Opinion From Radiologist, Technologist, and Patient	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).	Through study completion, enrollment expected to take up to 6-10 months at each site - Data collected from day of Breast Biopsy Procedure Only

Collaborators and Investigators

• Sponsor: Hologic, Inc.
• Investigators: Study Director: Brad Keller, Hologic, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2017
• Primary Completion (Actual): November 20, 2018
• Study Completion (Actual): November 20, 2018

Study Registration Dates

• First Submitted: February 20, 2018
• First Submitted That Met QC Criteria: February 28, 2018
• First Posted (Actual): March 7, 2018

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: September 17, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Breast Biopsy; Breast Biopsy Imaging; Stereotactic Imaging
• Other Study ID Numbers: 16-05A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes