Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2026-01-04 @ 4:37 AM
Study NCT ID:
NCT01957020
Status:
COMPLETED
Last Update Posted:
2013-10-16
First Post:
2013-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stereotactic Directional Vacuum-Assisted Breast Biopsy
Sponsor:
National Taiwan University Hospital
Organization:
Study Overview
Official Title:
The Diagnostic Accuracy of Stereotactic Directional Vacuum-Assisted Breast Biopsy
Status:
COMPLETED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Stereotactic directional vacuum-assisted breast biopsy (ST DVAB) is a standard biopsy procedure for suspicious findings on mammograms in Western countries for more than 10 years \[1-3\], it has replaced the needle localization (NLOC) excisional biopsy for the lesions alike and was reported to feature a high sensitivity, very low delayed false-negative rate (less than 2%)\[4,5\]. Moreover, it causes less scarring, less psychologic stress to patients and less morbidity compared with needle localization excisional biopsy \[6,7\]. However, its sensitivity, accuracy has seldom been reported in Asian countries \[8\] , since most Asian women have different breast parenchyma pattern, different breast cancer prevalence. Therefore, we retrospectively reviewed outcomes of the two groups of patients receiving either ST DVAB or NLOC excisional biopsy, trying to investigate if ST DVAB can be an effective alternative to NLOC excisional biopsy in our country.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: