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

NCT03300206 | Completed Results FDA Device

• 1 other identifier: 16-05B
• Study Type: observational
• Target: 525
• Locations: 1 country
• Sites: 7

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

Conditions

Breast Cancer Female

Keywords

Breast Biopsy; Breast Biopsy Imaging; Stereotactic Biopsy

Outcome Measures

Primary Outcomes (1)

• Difference in Procedural Time in Minutes

  The primary endpoint of this trial is the measured difference in procedure time between biopsies performed with the Brevera biopsy system and those performed with the standard-of-care biopsy systems at each clinical site. Additionally, feedback from the perspective of the participant radiologists, technologists, and subjects using the systems was reported.

  Average Time- Procedure (1 Lesion per subject): Total Time elapsed from when the subject enters the procedure room until they have left the procedure room, an average of 43 minutes.

Secondary Outcomes (3)

• Post-biopsy Complication Rates

  The time of consent until the subject procedure was completed, an average of 1 day

• Number of Samples Collected Per Lesion

  Samples collected from day of Breast Biopsy Procedure Only

• Percentage of Procedures With Overall Positive Opinion From Radiologists, Technologists and Patients

  Through study completion, enrollment expected to take up to 6-10 months at each participant site. Data collected from day of Breast Biopsy Procedure Only

Study Arms (2)

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

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

Interventions

Breast Biopsy DEVICE

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; Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only females (biologic) will be eligible for participation in the clinical trial.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female subjects who require a stereotactic breast biopsy procedure.

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 (7)

HonorHealth

Phoenix, Arizona, 85027, United States

Location

Kensington Medical Center - Kaiser Permanente

Kensington, Maryland, 29895, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Elizabeth Wende Breast Center

Rochester, New York, 14620, United States

Location

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Utah - Huntsman Cancer Hospital

Salt Lake City, Utah, 84112, United States

Location

Results Point of Contact

• Title: Hologic Clinical Research Team
• Organization: Hologic

ClinicalResearch@Hologic.com

508.263.2900

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: September 25, 2017
• First Posted: October 3, 2017
• Study Start: September 13, 2017
• Primary Completion: March 19, 2019
• Study Completion: March 19, 2019
• Last Updated: December 4, 2024
• Results First Posted: December 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)