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

Completed

• Conditions: Breast Cancer Female

• Registration Number: NCT03300206
• Lead Sponsor: Hologic, Inc.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-13
• Study First Submitted: 2017-09-25
• Study First Submitted QC: 2017-09-27
• Study First Posted: 2017-10-03
• Primary Completion: 2019-03-19
• Study Completion: 2019-03-19
• Results First Submitted: 2022-12-08
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-15
• Last Update Submitted: 2024-10-15
• Results First Posted: 2024-12-04
• Last Update Posted: 2024-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 525

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in Procedural Time in Minutes	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.	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.

Secondary Outcome Measures

Name	Time	Method
Post-biopsy Complication Rates	The time of consent until the subject procedure was completed, an average of 1 day	Adverse event percentage rates.
Number of Samples Collected Per Lesion	Samples collected from day of Breast Biopsy Procedure Only	Number of samples collected per lesion
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	The radiologists, technologists, and patients participating in this study were asked to provide feedback on the Brevera Biopsy System at the completion of each procedure. Their responses (raw scores) were reported and converted to percentage of procedures with overall positive opinion. The scale goes from 0% (poor/negative opinion) to 100% (excellent/positive opinion).

Trial Locations

Locations (7)

HonorHealth; 🇺🇸 Phoenix, Arizona, United States

Kensington Medical Center - Kaiser Permanente; 🇺🇸 Kensington, Maryland, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States

Elizabeth Wende Breast Center; 🇺🇸 Rochester, New York, United States

Magee-Womens Hospital of UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

University of Utah - Huntsman Cancer Hospital; 🇺🇸 Salt Lake City, Utah, United States