Magseed Magnetic Marker Localization

Breast Lesions Clinical Trial

Official title:

A Prospective, Open Label, Post Marketing Study of Magseed and Sentimag in Patients Undergoing Surgical Excision of a Breast Lesion That Requires Preoperative Radiographic Localization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03020888
• Other study ID #: US-002
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: July 2018

Study information

• Verified date: January 2021
• Source: Endomagnetics Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a post-market, prospective, open label, single arm study of Magseed and Sentimag in patients undergoing surgical excision of a breast lesion. Subjects will have the Magseed marker deployed under imaging guidance up to thirty days prior to surgery. The Magseed marker will be localized using the Sentimag system during surgery and removed with the lesion. After the lumpectomy procedure, subjects will be evaluated for safety and patient reported outcomes.

Other known NCT identifiers

• NCT03019445

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Breast Diseases
• Breast Lesions
• Disorders of Breast

Intervention

Device:
• Magseed and Sentimag
Magseed marker and Sentimag probe for lesion localization

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Endomagnetics Inc	M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Device Related Adverse Events	Rates of device-related adverse events and device-related serious adverse events	8 weeks
Secondary	Percent of Participants With Radiological Ease of Placement Rated as Very Easy, or Fairly Easy	Radiologist were asked to rate ease of marker placement graded from Very easy, Fairly Easy & Difficult after each marker placement.	At the time of marker deployment on average 8.39 minutes
Secondary	Percentage of Markers With Radiological Placement Accuracy Measured as <5mm to Lesion	Success rate of Magseed placement relative to the lesion (placement accuracy) measured as <5mm to lesion; 5-10mm to lesion; >10 mm to the target	At time of marker deployment on average 8.39 minutes
Secondary	Percentage of Participants With Re-excision	Overall re-excision rate and re-excision rate necessary to remove the Magseed or targeted lesion	During surgery on average 16 minutes
Secondary	Percent of Participants With Surgical Ease of Localization - Rated Fairly or Very Easy	Surgeon rated ease of localization during surgery assessed for each procedure as either very easy, fairly easy, fairly difficult, difficult, unable to localise	At time of surgery on average 16 minutes
Secondary	Surgical Localization - Duration of Localization	Duration of the lumpectomy procedure, time taken to remove the lesion	At time of surgery on average 16 minutes
Secondary	Percentage of Participants With Marker Retrieval Rated as Fairly or Very Easy	Pathologist rated ease of marker identification and retrieval as: 1) Unable to retrieve 2) Difficult 3) Fairly difficult 4)fairly easy 5) very easy	On the day of surgery