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

Breast Cancer Female Clinical Trial

Official title:

A Prospective, Block Stratified Clinical Trial to Evaluate the Performance and Operation of the Brevera Breast Biopsy System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03300206
• Other study ID #: 16-05B
• Status: Completed
• Start date: September 13, 2017
• Est. completion date: March 19, 2019

Study information

• Verified date: September 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 as compared to the current standard-of-care breast biopsy procedures

Recruitment information / eligibility

• Status: Completed
• Enrollment: 525
• Est. completion date: March 19, 2019
• Est. primary completion date: March 19, 2019
• 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:
• Breast Biopsy
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
United States	MD Anderson Cancer Center	Houston	Texas
United States	Kensington Medical Center - Kaiser Permanente	Kensington	Maryland
United States	HonorHealth	Phoenix	Arizona
United States	Magee-Womens Hospital of UPMC	Pittsburgh	Pennsylvania
United States	Elizabeth Wende Breast Center	Rochester	New York
United States	Washington University	Saint Louis	Missouri
United States	University of Utah - Huntsman Cancer Hospital	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Hologic, Inc.

Country where clinical trial is conducted

United States, 

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 - Data collected from day of Breast Biopsy Procedure Only
Secondary	Post-biopsy complication rates	Adverse event rates.	Through study completion - 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 - Data collected from day of Breast Biopsy Procedure Only
Secondary	Feedback from Radiologist, Technologist and Patient	Questionnaire Feedback	Through study completion - Data collected from day of Breast Biopsy Procedure Only