Magseed Magnetic Marker Localization

NCT03020888 | Completed Results

• 1 other identifier: US-002
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this post-marketing study is to provide prospective evidence that the Magseed and Sentimag® is effective for lesion localization in patients undergoing surgical excision of a breast lesion and to summarize measures of product safety and performance.

Conditions

Disorders of Breast; Breast Lesions

Outcome Measures

Primary Outcomes (1)

• Percent of Participants With Retrieval of Index Lesion and Magseed

  Percent retrieval rate of the index lesion and Magseed in the initial excised specimen. This is defined as the number of subjects in whom the index lesion and Magseed are retrieved in the initial excised specimen divided by the total number of subjects undergoing surgery.

  Time of surgery on average 16 minutes

Secondary Outcomes (7)

• Number of Device Related Adverse Events

  8 weeks

• Percent of Participants With Radiological Ease of Placement Rated as Very Easy, or Fairly Easy

  At the time of marker deployment on average 8.39 minutes

• Percentage of Markers With Radiological Placement Accuracy Measured as <5mm to Lesion

  At time of marker deployment on average 8.39 minutes

• Percentage of Participants With Re-excision

  During surgery on average 16 minutes

• Percent of Participants With Surgical Ease of Localization - Rated Fairly or Very Easy

  At time of surgery on average 16 minutes

Study Arms (1)

Magseed and Sentimag

EXPERIMENTAL

Magseed marker deployed to mark a breast lesion under imaging guidance up to 30 days prior to surgery. Marker located during surgery using the Sentimag system, and removed with the lesion.

Device: Magseed and Sentimag

Interventions

Magseed and Sentimag DEVICE

Magseed marker and Sentimag probe for lesion localization

Magseed and Sentimag

Eligibility Criteria

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

You may qualify if:

• Subjects with a breast lesion requiring image-guided localization prior to excision.
• Subjects aged 18 years or more at the time of consent.

You may not qualify if:

• The subject is pregnant or lactating.
• Subject has pacemaker or other implantable device in the chest wall.
• Subject has current active infection at the implantation site in the breast (per investigatordiscretion)

Sponsors & Collaborators

• Endomagnetics Inc: lead
• M.D. Anderson Cancer Center: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030-4008, United States

Location

MeSH Terms

Conditions

Breast Diseases

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr Matthew Womack
• Organization: Endomag

mwomack@endomag.com

+44 7851 247439

Study Officials

• Kelly Hunt, MD

  MD Anderson

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 13, 2017
• Study Start: January 1, 2017
• Primary Completion: February 1, 2018
• Study Completion: July 1, 2018
• Last Updated: February 4, 2021
• Results First Posted: January 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)