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

• Sponsor: Hologic, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03300206
• Collaborator: (none)
• Enrollment: 525
• Locations: 7
• Actual Duration (Months): 18.1
• Patients Per Site: 75
• Patients Per Site Per Month: 4.1

Study Details

Study Description

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 as compared to the current standard-of-care breast biopsy procedures

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Female	Device: Breast Biopsy

Study Design

• Study Type: Observational
• Actual Enrollment: 525 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Prospective, Block Stratified Clinical Trial to Evaluate the Performance and Operation of the Brevera Breast Biopsy System
• Actual Study Start Date: Sep 13, 2017
• Actual Primary Completion Date: Mar 19, 2019
• Actual Study Completion Date: Mar 19, 2019

Arms and Interventions

Arm	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.	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.
Standard of Care Each of the participating sites will currently be using a vacuum assisted breast biopsy system along with a specimen radiography system (or other specimen imaging system).	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.

Outcome Measures

Primary Outcome Measures

1. Procedural Time [Through study completion - Data collected from day of Breast Biopsy Procedure Only]

   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.

Secondary Outcome Measures

1. Post-biopsy complication rates [Through study completion - Data collected from day of Breast Biopsy Procedure Only]

   Adverse event rates.

2. Total tissue acquisition by number of cores and sample mass, [Through study completion - Data collected from day of Breast Biopsy Procedure Only]

   Tissue weight and number of cores collected

3. Feedback from Radiologist, Technologist and Patient [Through study completion - Data collected from day of Breast Biopsy Procedure Only]

   Questionnaire Feedback

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	HonorHealth	Phoenix	Arizona	United States	85027
2	Kensington Medical Center - Kaiser Permanente	Kensington	Maryland	United States	29895
3	Washington University	Saint Louis	Missouri	United States	63110
4	Elizabeth Wende Breast Center	Rochester	New York	United States	14620
5	Magee-Womens Hospital of UPMC	Pittsburgh	Pennsylvania	United States	15213
6	MD Anderson Cancer Center	Houston	Texas	United States	77030
7	University of Utah - Huntsman Cancer Hospital	Salt Lake City	Utah	United States	84112

Sponsors and Collaborators

• Hologic, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hologic, Inc.
• ClinicalTrials.gov Identifier: NCT03300206
• Other Study ID Numbers: 16-05B
• First Posted: Oct 3, 2017
• Last Update Posted: Sep 27, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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.: No
• Keywords provided by Hologic, Inc.: Breast Biopsy; Breast Biopsy Imaging; Stereotactic Biopsy

Study Results

No Results Posted as of Sep 27, 2019