14 g vs. 16 g in Breast Biopsy

University Hospital Tuebingen

Status: Completed

Conditions: Breast Biopsy

Treatments: Diagnostic Test: needle biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT03212040

Gauge 14/16

Details and patient eligibility

About

Comparison of biopsy needles with a different diameter, i.e. 14 vs 16 gauge, used for breast biopsies

Enrollment: 186 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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 2-5.
• Guideline-oriented indication for bioptic clarification

Exclusion criteria

• No reliable sonographic demarcation of the finding
• Pregnancy

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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186 participants in 2 patient groups

14 gauge needle biopsy

Active Comparator group

Description:

breast biopsy will be performed with 14 gauge needle

Treatment:

Diagnostic Test: needle biopsy

16 gauge needle biopsy

Active Comparator group

Description:

breast biopsy will be performed with 16 gauge needle

Treatment:

Diagnostic Test: needle biopsy