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

NCT04911101 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-03-08

No results posted yet for this study

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

Conditions

  • Breast Diseases

Interventions

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

Sponsors & Collaborators

  • Stockholm South General Hospital

    collaborator OTHER

  • Capio Sankt Görans Hospital

    collaborator OTHER

  • Uppsala University Hospital

    collaborator OTHER

  • Karolinska University Hospital

    lead OTHER

Principal Investigators

  • Fredrik Strand, MD PhD · Karolinska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-19
Primary Completion
2023-05-31
Completion
2024-05-31
FDA Device
Yes

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04911101 on ClinicalTrials.gov