N/A
Completed N=500
Brevera™ Breast Biopsy System Data Collection Study
Breast Cancer Female
Source: ClinicalTrials.gov NCT03456583 ↗
Enrolled (actual)
500
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcomePrimary: Procedural Time — 38.44 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Procedural Time |
38.44 | — |
| SECONDARY Post-biopsy Complication Rates |
11 | — |
| SECONDARY Average Number of Cores Per Lesion |
10.58 | — |
| SECONDARY Percentage of Procedures With Overall Positive Opinion From Radiologist, Technologist, and Patient |
76.3; 66.9; 96.8 | — |
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 (NCT03456583). 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.