Clinical trial · Interventional
Evaluation of the SmartBx System for Breast Biopsy
Evaluation of the SmartBx System for Breast Biopsy Download While Keeping the Orientation, Unfolding and Unity of the Sample
NCT03808116CI-TRIAL-00048154completedN/AClinicalTrials.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)
Performance evaluation of a novel, semi-automated device and method for needle core biopsy download compared to standard methods in terms of: 3\. Biopsy core length obtained (i.e. collecting all tissue fragments) 4. Biopsy core yield (i.e. percent of tissue loss during the pathologic processing)
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 | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SmartBx | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SmartBx biopsy collection
- description
- * Biopsy cores will be collected from the breast during US guided biopsy procedure. * The number of cores taken will be decided per the physician discretion according to the clinical demand. * Additional two biopsy core will be taken the SmartBx cassette
- interventionNames
- Device: SmartBx
Primary outcomes (2)
- measure
- biopsy core length
- timeFrame
- 1 month
- description
- biopsy core length will be measured on the glass slide
- measure
- biopsy core yield
- timeFrame
- 1 month
- description
- biopsy core length will be measured on the needle and on the glass slide and for each core the length on the slide will be computed in reference to the length on the needle
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years or older * Planned for breast biopsy procedure. * Signed informed consent. Exclusion Criteria: o Patient's unwilling to participate.
References
Publications (0)
Data not yet available
No reference posted for this study.