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

NCT02975128 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2020-05-29

No results posted yet for this study

Summary

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

Conditions

  • Breastcancer

Interventions

DEVICE

BLES system and conventional lumpectomy

Each patient undergoes the same procedure. Under general anaesthesia for the normal surgical procedure, the tumor is first removed using the BLES system under US guidance. Next, the normal surgical procedure is performed, excising the BLES excision cavity and a ≥ 1cm margin of surrounding tissue, also guided by the US appearance after the BLES procedure.

Sponsors & Collaborators

  • Canisius-Wilhelmina Hospital

    collaborator OTHER

  • Dutch Cancer Society

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Ritse Mann, MD, PhD · Radboud University Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-19
Primary Completion
2019-07-31
Completion
2019-07-31

Countries

  • Netherlands

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 NCT02975128 on ClinicalTrials.gov