Clinical trial · Interventional
Accuracy of VABB Elite 10G Versus BARD 14G CNB
Accuracy of Vacuum-assisted Breast Biopsy Elite 10G Versus BARD 14G Core Needle Biopsy of Abnormal Breast Lesions.
NCT04612439CI-TRIAL-00053870unknownPhase 3ClinicalTrials.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)
In this study, patients whose breast ultrasound showed a space-occupying lesion and needed biopsy to clarify the pathology were selected as the research subjects. This study aims to determine whether Vacuum-assisted biopsy device Elite is superior to the traditional BARD ejection type air core needle in the diagnosis of breast cancer through a prospective randomized study.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BARD 14G CNB | Device | — | UNRESOLVED |
| VABB Elite 10G | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- VABB Elite 10G
- description
- Vacuum-assisted Elite 10G
- interventionNames
- Device: VABB Elite 10G
- type
- ACTIVE_COMPARATOR
- label
- BARD 14G CNB
- description
- BARD 14G Core needle
- interventionNames
- Device: BARD 14G CNB
Primary outcomes (1)
- measure
- Accuracy
- timeFrame
- 3 months
- description
- The accuracy of the puncture pathology was defined as the proportion of patients in the study population who were consistent with the qualitative diagnosis of the puncture pathology and surgical pathology.When the pathological diagnosis of puncture is "carcinoma in situ of the catheter", if the pathological diagnosis of the catheter is "carcinoma in situ of the catheter with microinfiltration", the puncture is considered accurate;If the surgical pathology confirms "invasive cancer (infiltrating lesion \>1mm)", the pathology of the puncture is considered inaccurate (ie, underestimated)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Over 18 years old (including 18 years old) * Ultrasound examination indicates the presence of space-occupying lesions in the breast. The size, location, and BI-RADS classification are not limited. * Agree to undergo surgery after puncture * Ability and willingness to sign informed consent Exclusion Criteria: * A biopsy has been performed in the external hospital * Contraindications for puncture or surgery such as severe coagulation dysfunction * Refuse breast surgery * Axillary lymph node puncture
References
Publications (1)
- DERIVEDZhang Y, Li J, Mo M, Shen J, Ren H, Li S, Liu G, Shao Z. The comparison of efficacy and safety evaluation of vacuum-assisted Elite 10-G system and the traditional BARD 14-G core needle in breast diagnosis: an open-label, parallel, randomized controlled trial. Int J Surg. 2023 May 1;109(5):1180-1187. doi: 10.1097/JS9.0000000000000257. PMID 37042316