Accuracy of VABB Elite 10G Versus BARD 14G CNB

Fudan University

Status and phase: Unknown; Phase 3

Conditions: Breast Cancer

Treatments: Device: VABB Elite 10G; Device: BARD 14G CNB

Study type: Interventional

Funder types: Other

Identifiers

NCT04612439

2008222-12

Details and patient eligibility

About

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.

Full description

The main purpose of the study was to analyze the difference in the accuracy of two biopsy devices in the diagnosis of breast cancer puncture. The purpose of the secondary study was to analyze the difference between the underestimation rate, false negative rate, sensitivity, and negative predictive value of the two devices, the consistency of the immunohistochemistry between the puncture pathology and surgical pathology of the two groups of patients, the number and time-consuming of the puncture acquisition specimens, and the two biopsies Differences in the incidence of complications (safety).

If the biopsy device is a vacuum-assisted Elite 10G needle, insert the needle groove into the mass and rotate to cut the biopsy tissue one circle; If the biopsy device is a BARD 14G hollow core needle, insert the needle to the edge of the mass and pull the trigger in different directions to eject the needle to retrieve the material.

Enrollment: 1,470 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,470 participants in 2 patient groups

VABB Elite 10G

Experimental group

Description:

Vacuum-assisted Elite 10G

Treatment:

Device: VABB Elite 10G

BARD 14G CNB

Active Comparator group

Description:

BARD 14G Core needle

Treatment:

Device: BARD 14G CNB