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