14 g vs. 16 g in Breast Biopsy

NCT ID: NCT03212040

Last Updated: 2024-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-05

Study Completion Date

2018-06-07

Brief Summary

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

Detailed Description

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Conditions

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Breast Biopsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Comparison of 14 vs 16 gauge needles
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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14 gauge needle biopsy

breast biopsy will be performed with 14 gauge needle

Group Type ACTIVE_COMPARATOR

needle biopsy

Intervention Type DIAGNOSTIC_TEST

breast biopsy using different needle gauges

16 gauge needle biopsy

breast biopsy will be performed with 16 gauge needle

Group Type ACTIVE_COMPARATOR

needle biopsy

Intervention Type DIAGNOSTIC_TEST

breast biopsy using different needle gauges

Interventions

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needle biopsy

breast biopsy using different needle gauges

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Women's Health

Tübingen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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Gauge 14/16

Identifier Type: -

Identifier Source: org_study_id

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