14 g vs. 16 g in Breast Biopsy

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

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

Study Overview

• Status: Completed
• Conditions: Breast Biopsy
• Intervention / Treatment: Diagnostic test: needle biopsy

• Study Type: Interventional
• Enrollment (Actual): 186
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Tübingen, Germany, 72076
    • Department of Women's Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 14 gauge needle biopsy; breast biopsy will be performed with 14 gauge needle	Diagnostic test: needle biopsy; breast biopsy using different needle gauges
Active Comparator: 16 gauge needle biopsy; breast biopsy will be performed with 16 gauge needle	Diagnostic test: needle biopsy; breast biopsy using different needle gauges

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain related to the biopsy procedure	Subjective pain perception measured visual analog scale	1 year
Duration time of the biopsy procedure	Duration time of the biopsy procedure	1 year

Collaborators and Investigators

• Sponsor: University Women's Hospital Tübingen

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2011
• Primary Completion (Actual): February 18, 2013
• Study Completion (Actual): June 7, 2018

Study Registration Dates

• First Submitted: June 27, 2017
• First Submitted That Met QC Criteria: July 5, 2017
• First Posted (Actual): July 11, 2017

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 12, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Gauge 14/16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No