TerminatedNot Applicable

Minimal Invasive Breast Cancer Excision Using the Breast Lesion Excision System Under Ultrasound Guidance

Stopped: Needle production stopped

Netherlands22 participantsStarted 2018-02-19

Plain-language summary

This study will assess whether it is feasible to remove small breast cancers completely using the Breast Lesion Excision System under Ultrasound guidance.

Who can participate

Age range19 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Female * 19 years or older * US visible breast cancer with maximum diameter of 15 mm on US * Histologically proven invasive breast cancer * Willing and able to undergo preoperative breast MRI * Able to provide informed consent Exclusion Criteria: * Poor US visibility of the breast cancer * Breast cancer closer than 6 mm to the dermis, nipple or pectoral muscle. * Contra-indications to breast MRI or intravenous contrast administration * Contra-indications for the use of diathermia * Unable to provide informed consent * Patients with breast implants * Patients with implanted electronics * Pregnancy * Neoadjuvant chemotherapy

What they're measuring

Frequency of successful complete tumor excision by the BLES system.

Timeframe: Through study completion, an average of two months

Trial details

NCT IDNCT02975128

SponsorRadboud University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-07-31

View on ClinicalTrials.gov More Breastcancer trials