Magseed Magnetic Marker Localization

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Disorders of Breast, Breast Lesions

Intervention / Treatment
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* Device: Magseed and Sentimag


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magseed and Sentimag<br>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<br>* Magseed marker and Sentimag probe for lesion localization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Device Related Adverse Events | Rates of device-related adverse events and device-related serious adverse events | 8 weeks | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Surgical Localization - Duration of Localization | Duration of the lumpectomy procedure, time taken to remove the lesion | At time of surgery on average 16 minutes | 
| 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 |