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A Trial of a New Magnetic Breast Marking Clip

NCT02378558 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2023-12-14

No results posted yet for this study

Summary

This small pilot will allow surgeons to perform wireless breast lumpectomies using a new magnetic technology. This is a continuation of a previous project testing the technology, and the breast surgeons comfort level using this new technology.

The aim of this project is to develop a new technique for surgical excision of lesions either through surgical biopsy or lumpectomy. The current standard of care involves placing a needle then slender wire through the lesion under image guidance by a radiologist. The surgeon then removes the lesion using the wire as a guide. This new technique would place a magnet through the lesion under image guidance by a radiologist. The surgeon would then use the MagneProbe in the operating room to locate the magnet and remove the lesion. This new technique would eliminate the use of a wire that protrudes from a patient's breast. This wire is usually placed on the day of surgery, prior to the procedure. The goal of this new technique is to eliminate wire placement and increase patient comfort throughout the day of her surgery.

Conditions

  • Breast Neoplasms

Interventions

DEVICE

MagneMarker

The MagneMarker system includes a magnetic clip the MagneMarker, a clip placement device the MagneJector, and a magnetic field detecting probe the MagneProbe. The MagneMarker and MagneJector are used by a radiologist during a breast localization procedure. The MagneProbe is used by a surgeon to locate the MagneMarker during breast excision.

Sponsors & Collaborators

  • MagneMark LLC

    collaborator UNKNOWN

  • Antonios Likourezos

    lead OTHER

Principal Investigators

  • Donna Marie Manasseh, MD · Chief, Division of Breast Surgery Director, Maimonides Breast Cancer Program Maimonides Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2018-08-31
Completion
2018-08-31

Countries

  • United States

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 NCT02378558 on ClinicalTrials.gov