Brevera™ Breast Biopsy System Data Collection Study

NCT03456583 | Completed Results FDA Device

• 1 other identifier: 16-05A
• Study Type: observational
• Target: 500
• Locations: 6 countries
• Sites: 6

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.

Conditions

Breast Cancer Female

Keywords

Breast Biopsy; Breast Biopsy Imaging; Stereotactic Imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

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

Interventions

Brevera Breast Biopsy System DEVICE

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.

Brevera Breast Biopsy System

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hologic, Inc.: lead

Study Sites (6)

Institut régional du Cancer de Montpellier

Montpellier, France

Location

Brustdiagnostik Munchen

Tübingen, Germany

Location

Radiologia Senologica

Milan, Italy

Location

Noordwest Ziekenhuisgroep

Alkmaar, Netherlands

Location

Centro de Patalogia de la Mama-Fundacion Tejerina

Madrid, Spain

Location

Royal Free Londan NHS Foundation Trust

London, United Kingdom

Location

Results Point of Contact

• Title: Muhammad Waqas
• Organization: Hologic

Muhammad.Waqas@hologic.com

5088267183

Study Officials

• Brad Keller

  Hologic, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: March 7, 2018
• Study Start: November 20, 2017
• Primary Completion: November 20, 2018
• Study Completion: November 20, 2018
• Last Updated: October 8, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); IT (1); DE (1); GB (1); NL (1); FR (1)