Status:

UNKNOWN

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

Lead Sponsor:

Karolinska University Hospital

Collaborating Sponsors:

Stockholm South General Hospital

Capio Sankt Görans Hospital

Conditions:

Breast Diseases

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

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

Detailed Description

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 10...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • Age less than 18 years of age
  • Inability to understand the meaning of informed consent
  • Pregnancy
  • Breast-feeding

Key Trial Info

Start Date :

November 19 2019

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 1 2024

Estimated Enrollment :

150 Patients enrolled

Trial Details

Trial ID

NCT04911101

Start Date

November 19 2019

End Date

May 1 2024

Last Update

March 8 2023

Active Locations (1)

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1

Karolinska University Hospital

Stockholm, Sweden, 17164