N/A N=525

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

Breast Cancer Female

Bottom Line

View on ClinicalTrials.gov: NCT03300206 ↗

Enrolled (actual)

525

Serious AEs

0.0%

Results posted

Dec 2024

Primary outcome: Primary: Difference in Procedural Time in Minutes — 42.15; 40.13 procedure time in minutes

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Breast Biopsy (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Hologic, Inc.
Primary completion: Mar 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Difference in Procedural Time in Minutes	42.15; 40.13	—
SECONDARY Post-biopsy Complication Rates	9; 4	—
SECONDARY Number of Samples Collected Per Lesion	6.69; 7.25	—
SECONDARY Percentage of Procedures With Overall Positive Opinion From Radiologists, Technologists and Patients	79.8; 72.8; 99.0	—

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

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03300206). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.