NCT03020888

Magseed Magnetic Marker Localization

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Endomagnetics Inc · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Disorders of Breast
• Breast Lesions

Interventions

Type	Name	Description
DEVICE	Magseed and Sentimag	Magseed marker and Sentimag probe for lesion localization

Timeline

• Start date: 2017-01-01
• Primary completion: 2018-02-01
• Completion: 2018-07-01
• First posted: 2017-01-13
• Last updated: 2021-02-04
• Results posted: 2021-01-15

Locations

1 site across 1 country: United States