Performance Indicators and Patient Experience in 7G and 10G Vacuum-assisted Excision of Probably Benign Breast Lesions

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-19

Study Completion Date

2024-05-31

Brief Summary

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The purpose of this study is to assess how the needle size 7G vs 10G affects performance indicators and patient experience in vacuum-assisted excision (VAE) of probably benign breast lesions

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Detailed Description

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After being informed about the study and potential risks, all patients giving written informed consent will have a VAE procedure to remove their breast lesion and will be randomised to either 7G or 10G needle size. After completion of the procedure, the patients fill out a questionnaire to collect data on their experience. The radiologist performing the procedure fills out a form collecting procedural performance indicators.

Conditions

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Breast Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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7G needle

7G needle dimension used

Group Type EXPERIMENTAL

Excision with 7G needle

Intervention Type DEVICE

Vacuum-assisted excision using a biopsy needle with two alternative dimensions

10G needle

10G needle dimension used

Group Type EXPERIMENTAL

Excision with 10G needle

Intervention Type DEVICE

Vacuum-assisted excision using a biopsy needle with two alternative dimensions

Interventions

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Excision with 7G needle

Vacuum-assisted excision using a biopsy needle with two alternative dimensions

Intervention Type DEVICE

Excision with 10G needle

Vacuum-assisted excision using a biopsy needle with two alternative dimensions

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Biopsy-verified probably benign breast lesion less than 20 mm size
* Biopsy-verified benign breast lesion less than 30 mm size
* Screen-detected group of microcalcifications under 10 mm size