Magseed Magnetic Marker Localization

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-07-31

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.

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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.

Conditions

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Disorders of Breast Breast Lesions

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Magseed and Sentimag

Intervention Type DEVICE

Magseed marker and Sentimag probe for lesion localization

Interventions

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Magseed and Sentimag

Magseed marker and Sentimag probe for lesion localization

Intervention Type DEVICE

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)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No