RecruitingNot ApplicableNCT05142787

Magseed Pro(R)/ Sentimag(R) Gen3

A Prospective, Multi Center, International, Open Label Study of the Use of Magseed Pro(R) Markers and Sentimag(R) Gen3 to Localize Breast Lesions and Suspicious/Biopsy-proven Positive Lymph Nodes in Breast Cancer Patients

Sponsor

Endomagnetics Ltd.

Enrollment

224 participants

Start Date

Mar 2, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

Summary

The purpose of this study is to provide prospective evidence that the Magseed Pro® marker /Sentimag® Gen3 system is safe and effective for marking A. suspicious/biopsy-proven positive axillary lymph nodes; and B. soft tissue lesions including cancer and pre-cancerous change in the breast

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a device called the Magseed Pro, used with a magnetic detection system (Sentimag Gen3), to mark breast lumps or lymph nodes before surgery so surgeons can find and remove them more accurately. This is an alternative to traditional wire localization. **You may be eligible if...** - You are 18 years or older - You need a breast lump or lymph node marked and removed as part of your treatment - You are able and willing to give informed consent **You may NOT be eligible if...** - You are pregnant, nursing, or planning to become pregnant during the study - You have a known allergy to Nitinol (the metal the device is made from) - You have an active infection at the implantation site - You have other medical, social, or psychological conditions that could affect your ability to participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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