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
Endomagnetics Ltd.
224 participants
Mar 2, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- Participant is willing and able to give informed consent for participation in the study
- Participant is aged 18 years or older at the time of consent.
- Patients requiring breast lesion/axillary node marking and excision
Exclusion Criteria3
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical trial or to comply with follow up requirements, or impact the scientific soundness of the clinical trial results
- Known hypersensitivity to Nitinol
- Subject has current active infection at the implantation site in the breast (per investigator discretion)
Interventions
placement of Magseed Pro \& localisation with Sentimag Gen3 in axillary lymph nodes and/or breast lesions
Locations(6)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05142787