Accuracy of VABB Elite 10G Versus BARD 14G CNB

Breast Cancer Clinical Trial

Official title: Accuracy of Vacuum-assisted Breast Biopsy Elite 10G Versus BARD 14G Core Needle Biopsy of Abnormal Breast Lesions.

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Breast Cancer

• NCT number: NCT04612439
• Study type: Interventional
• Source: Fudan University
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 1, 2020
• Completion date: June 30, 2022