14 g vs. 16 g in Breast Biopsy

Breast Biopsy Clinical Trial

Official title:

Comparison of Needle Gauge 14 vs. Gauge 16 in Breast Biopsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03212040
• Other study ID #: Gauge 14/16
• Status: Completed
• Phase: N/A
• Start date: December 5, 2011
• Est. completion date: June 7, 2018

Study information

• Verified date: February 2019
• Source: University Women's Hospital Tübingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: June 7, 2018
• Est. primary completion date: February 18, 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Biopsy

Intervention

Diagnostic Test:
• needle biopsy
breast biopsy using different needle gauges

Locations

Country	Name	City	State
Germany	Department of Women's Health	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
University Women's Hospital Tübingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy	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	1 year
Primary	Diagnostic quality	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	1 year
Secondary	Pain related to the biopsy procedure	Subjective pain perception measured visual analog scale	1 year
Secondary	Duration time of the biopsy procedure	Duration time of the biopsy procedure	1 year