Magseed Magnetic Marker Localization

Endomagnetics

Status: Completed

Conditions: Disorders of Breast; Breast Lesions

Treatments: Device: Magseed and Sentimag

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03020888

US-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Magseed and Sentimag

Experimental group

Description:

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.

Treatment:

Device: Magseed and Sentimag