Brevera™ Breast Biopsy System Data Collection Study

Completed

• Conditions: Breast Cancer Female
• Interventions: Device: Brevera Breast Biopsy System

• Registration Number: NCT03456583
• Lead Sponsor: Hologic, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-20
• Study First Submitted: 2018-02-20
• Study First Submitted QC: 2018-02-28
• Study First Posted: 2018-03-07
• Primary Completion: 2018-11-20
• Study Completion: 2018-11-20
• Results First Submitted: 2021-11-02
• Results First Submitted QC: 2024-04-26
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-17
• Results First Posted: 2024-09-19
• Last Update Posted: 2024-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Brevera Breast Biopsy System	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (6)

Institut régional du Cancer de Montpellier; 🇫🇷 Montpellier, France

Radiologia Senologica; 🇮🇹 Milan, Italy

Noordwest Ziekenhuisgroep; 🇳🇱 Alkmaar, Netherlands

Royal Free Londan NHS Foundation Trust; 🇬🇧 London, United Kingdom

Brustdiagnostik Munchen; 🇩🇪 Tübingen, Germany

Centro de Patalogia de la Mama-Fundacion Tejerina; 🇪🇸 Madrid, Spain