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Clinical Trials in Germany / NCT05142787
Recruiting Not applicable

Magseed Pro(R)/ Sentimag(R) Gen3

NCT05142787 · tracked via the Priya Life Science Germany tracker
Sponsor
Endomagnetics Ltd
Phase
Not applicable
Started
2023-03-02
Last updated
2026-09-16

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Magseed Pro(R) and Sentimag(R) Gen3 by Endomagnetics

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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

  • 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
    This is defined as the number of patients with successful Magseed Pro® marker placement as demonstrated on imaging, in whom the Magseed Pro® marker and the associated lymph node and/ or lesion is retrieved, divided by the total number of subjects.

Trial sites (6)

FacilityCityRegionStatus
Marienhospital Bottrop GmbH Bottrop Germany Recruiting
AGAPLESION Markus Frankfurter Diakonie Kliniken gGmbH Frankfurt Germany Recruiting
Technical University Munich Munich Germany Not Yet Recruiting
Guy's Hospital London United Kingdom Recruiting
Royal Marsden Hospital London United Kingdom Recruiting
University Hospital South Manchester Manchester United Kingdom Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05142787 on ClinicalTrials.gov ↗ ← All trials in Germany