14 g vs. 16 g in Breast Biopsy
Comparison of Needle Gauge 14 vs. Gauge 16 in Breast Biopsy
1 other identifier
interventional
186
1 country
1
Brief Summary
Comparison of biopsy needles with a different diameter, i.e. 14 vs 16 gauge, used for breast biopsies
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 5, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 18, 2013
CompletedFirst Submitted
Initial submission to the registry
June 27, 2017
CompletedFirst Posted
Study publicly available on registry
July 11, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 7, 2018
CompletedJuly 22, 2024
February 1, 2019
1.2 years
June 27, 2017
July 19, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Pain related to the biopsy procedure
1 year
Duration time of the biopsy procedure
1 year
Study Arms (2)
14 gauge needle biopsy
ACTIVE COMPARATORbreast biopsy will be performed with 14 gauge needle
16 gauge needle biopsy
ACTIVE COMPARATORbreast biopsy will be performed with 16 gauge needle
Interventions
breast biopsy using different needle gauges
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- No reliable sonographic demarcation of the finding
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Women's Health
Tübingen, 72076, Germany
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2017
First Posted
July 11, 2017
Study Start
December 5, 2011
Primary Completion
February 18, 2013
Study Completion
June 7, 2018
Last Updated
July 22, 2024
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share