Comparison of Needle Gauge 14 vs. Gauge 16 in Breast Biopsy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 186
- Locations
- 2
- Primary Endpoint
- Diagnostic quality
Study Overview
Brief Summary
Comparison of biopsy needles with a different diameter, i.e. 14 vs 16 gauge, used for breast biopsies
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Minimum age of 18 years
- •Informed consent available
- •Palpable and non-palpable breast findings
- •Tumor size 5-20 mm
- •Findings of sonographic BI-RADS® classification 2-
- •Guideline-oriented indication for bioptic clarification
Exclusion Criteria
- •No reliable sonographic demarcation of the finding
- •Pregnancy
Outcomes
Primary Outcomes
Diagnostic quality
Time Frame: 1 year
* Diagnostic quality of specimen to achieve an accurate histological diagnosis * Diagnostic quality of specimen to achieve an accurate histological diagnosis, with 1 to 5 passes of core needle biopsy * Additive diagnostic quality to achieve a high (\>=99%) diagnostic yield, with 1-5 passes of core needle biopsy
Diagnostic accuracy
Time Frame: 1 year
* Diagnostic aggreement (representativity) with definitive histology of core needle specimen and of surgical specimen * Additive diagnostic aggreement (representativity) with definitive histology of core needle specimen and with histology of surgical specimen, with 1 to 5 passes of core needle biopsy * Additive diagnostic accuracy to achieve a high (\>=99%) diagnostic yield, with 1-5 passes of core needle biopsy
Secondary Outcomes
- Duration time of the biopsy procedure(1 year)
- Pain related to the biopsy procedure(1 year)