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OpenTrials
Completed

NCT Number: NCT03212040

14 g vs. 16 g in Breast Biopsy

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

Completed

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Key information

Conditions

Breast Biopsy

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Women's Health

Tübingen, 72076, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

needle biopsy

Diagnostic Test

breast biopsy using different needle gauges

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Pain related to the biopsy procedure

    Time frame: 1 year

    Subjective pain perception measured visual analog scale

  2. Duration time of the biopsy procedure

    Time frame: 1 year

    Duration time of the biopsy procedure

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2018
First posted
Jul 11, 2017
Registry last updated
Jul 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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