N/A
Completed N=525
A Post-Market Clinical Trial to Evaluate the Performance and Operation of the Brevera Breast Biopsy System
Breast Cancer Female
Source: ClinicalTrials.gov NCT03300206 ↗
Enrolled (actual)
525
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcomePrimary: Difference in Procedural Time in Minutes — 42.15; 40.13 procedure time in minutes
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
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 | — |
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.
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. Informational only — not medical advice.