Brevera™ Breast Biopsy System Data Collection Study

Breast Cancer Female Clinical Trial

Official title:

A Prospective Study To Evaluate The Performance And Operation Of The Brevera™ Breast Biopsy System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03456583
• Other study ID #: 16-05A
• Status: Completed
• Start date: November 20, 2017
• Est. completion date: November 20, 2018

Study information

• Verified date: February 2019
• Source: Hologic, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: November 20, 2018
• Est. primary completion date: November 20, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Female

Intervention

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.

Locations

Country	Name	City	State
France	Institut régional du Cancer de Montpellier	Montpellier
Germany	Brustdiagnostik Munchen	Tübingen
Italy	Radiologia Senologica	Milan
Netherlands	Noordwest Ziekenhuisgroep	Alkmaar
Spain	Centro de Patalogia de la Mama-Fundacion Tejerina	Madrid
United Kingdom	Royal Free Londan NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Hologic, Inc.

Countries where clinical trial is conducted

France,  Germany,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedural Time	The primary endpoint of this trial is the measured difference in procedure time between biopsies performed with the Brevera biopsy system with real time imaging and biopsies performed using the standard-of-care biopsy system at each clinical site.	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	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
Secondary	Total tissue acquisition by number of cores and sample mass	Tissue weight and number of cores collected	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	Feedback from Radiologist, Technologist and Patient	Questionnaire Feedback using a Likert Scale (Pre-coded responses with the neutral point being neither agree nor disagree). The total averages will be compiled from the survey responses for marketing claims purposes.	Through study completion, enrollment expected to take up to 6-10 months at each site - Data collected from day of Breast Biopsy Procedure Only