Clinical trial · Observational
Brevera™ Breast Biopsy System Data Collection Study
A Prospective Study To Evaluate The Performance And Operation Of The Brevera™ Breast Biopsy System
NCT03456583CI-TRIAL-00081381completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brevera Breast Biopsy System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Brevera Breast Biopsy System
- description
- 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. 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.
- interventionNames
- Device: Brevera Breast Biopsy System
Primary outcomes (1)
- measure
- Procedural Time
- timeFrame
- Through study completion, enrollment expected to take up to 6-10 months at each site - Data collected from day of Breast Biopsy Procedure Only
- description
- Total time elapsed between from when the subject enters the procedure room until she has left the procedure room.
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.