Magseed Magnetic Marker Localization

Not Applicable

Completed

Conditions: Disorders of Breast
Breast Lesions

Interventions: Device: Magseed and Sentimag

Registration Number: NCT03020888

Lead Sponsor: Endomagnetics Inc

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.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 120

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Magseed and Sentimag	Magseed and Sentimag	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.

Primary Outcome Measures

Name	Time	Method
Percent of Participants With Retrieval of Index Lesion and Magseed	Time of surgery on average 16 minutes	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.

Secondary Outcome Measures

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