NCT04911101

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Karolinska University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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

• Breast Diseases

Interventions

Type	Name	Description
DEVICE	Excision with 7G needle	Vacuum-assisted excision using a biopsy needle with two alternative dimensions
DEVICE	Excision with 10G needle	Vacuum-assisted excision using a biopsy needle with two alternative dimensions

Timeline

• Start date: 2019-11-19
• Primary completion: 2023-05-01
• Completion: 2024-05-01
• First posted: 2021-06-02
• Last updated: 2023-03-08

Locations

1 site across 1 country: Sweden

Regulatory

• FDA-regulated device study