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

Karolinska University Hospital

Status: Enrolling

Conditions: Breast Diseases

Treatments: Device: Excision with 7G needle; Device: Excision with 10G needle

Study type: Interventional

Funder types: Other

Identifiers

NCT04911101

K2019-7986

Details and patient eligibility

About

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

Full 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 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

7G needle

Experimental group

Description:

7G needle dimension used

Treatment:

Device: Excision with 7G needle

10G needle

Experimental group

Description:

10G needle dimension used

Treatment:

Device: Excision with 10G needle