A Trial of a New Magnetic Breast Marking Clip

NCT02378558 | Terminated

• 2 other identifiers: 2015-03-08MagneMark_02
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Breast Surgery

Outcome Measures

Primary Outcomes (1)

• Completeness of Excision

  Investigators anticipate that cases using this localization and excision technique will be successful at minimum 96% of the time. The rate at which excision is successful using traditional methods. This outcome will be assessed and presented at the completion of the trial at the end of one year

  1 year

Secondary Outcomes (1)

• Time for excision

  1 year

Study Arms (1)

Investigational Device

EXPERIMENTAL

All patients will undergo breast localization and excision of a lesion using the MagneMark system. The radiologist will insert the MagneMarker clip into the area of concern using the MagneJector device. The surgeon will then locate the MagneMaker clip using the MagneProbe. The clip and breast tissue of concern will then be removed.

Device: MagneMarker

Interventions

MagneMarker DEVICE

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.

Investigational Device

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• i) Female ii) Ages 19-100 iii) Have a single breast lesion that has been previously biopsied and iv) Is discretely identified by:
• A metallic biopsy site marker or
• Ultrasound or
• Mammography and v) Is scheduled for preoperative needle localization with a single wire and vi) Is English speaking vii) Is capable of making medical decisions, not cognitively impaired viii) Is being localized by a study radiologist or can be rescheduled to be localized by a study radiologist

You may not qualify if:

• i) Cognitively impaired adults ii) Non- English speakers ii) Men

Sponsors & Collaborators

• Antonios Likourezos: lead
• MagneMark LLC: collaborator

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11220, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Donna Marie Manasseh, MD

  Chief, Division of Breast Surgery Director, Maimonides Breast Cancer Program Maimonides Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Administration Director

Study Record Dates

• First Submitted: February 19, 2015
• First Posted: March 4, 2015
• Study Start: March 1, 2015
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: December 14, 2023

Record last verified: 2023-12

Locations

US (1)