Recruiting
Magseed Pro(R)/ Sentimag(R) Gen3
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
ClinicalTrials.gov IDNCT05142787
PhaseNA
Enrollment224
SponsorEndomagnetics Ltd.
Age18 Years and older
SexALL
Conditions studied
Breast Cancer
About this study
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
Interventions
- Device: Magseed Pro(R) and Sentimag(R) Gen3 by Endomagnetics — placement of Magseed Pro \& localisation with Sentimag Gen3 in axillary lymph nodes and/or breast lesions
Primary outcomes
- The primary endpoints are the retrieval rates of the Magseed Pro® marker with the target lesion within the initial excised specimen for A.) axillary lymph nodes B.) breast lesions A.) axillary lymph nodes. B.) breast lesions (time of surgery)
Eligibility information
Inclusion Criteria:
* 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 Criteria:• Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period. A pregnancy test is required for all women of childbearing potential within 7 days before enrolment.
* 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)
Study locations
- Marienhospital Bottrop GmbH, Bottrop, Germany
- AGAPLESION Markus Frankfurter Diakonie Kliniken gGmbH, Frankfurt, Germany
- Technical University Munich, Munich, Germany
- Guy's Hospital, London, United Kingdom
- Royal Marsden Hospital, London, United Kingdom
- University Hospital South Manchester, Manchester, United Kingdom
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-14.