Clinical trial · Observational
A Post-Market Clinical Trial to Evaluate the Performance and Operation of the Brevera Breast Biopsy System
A Prospective, Block Stratified Clinical Trial to Evaluate the Performance and Operation of the Brevera Breast Biopsy System
NCT03300206CI-TRIAL-00083300completedResults 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 as compared to the current standard-of-care breast biopsy procedures
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 |
|---|---|---|---|
| Breast Biopsy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- 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.
- interventionNames
- Device: Breast Biopsy
- label
- Standard of Care
- description
- Each of the participating sites will currently be using a vacuum assisted breast biopsy system along with a specimen radiography system (or other specimen imaging system).
- interventionNames
- Device: Breast Biopsy
Primary outcomes (1)
- measure
- Difference in Procedural Time in Minutes
- timeFrame
- 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.
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.