Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260917-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Magseed Pro(R) and Sentimag(R) Gen3 by Endomagnetics | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- axillary lymph nodes requiring localisation prior to surgical excision
- description
- The Magseed Pro® marker is intended to be placed percutaneously in suspicious/biopsy proven positive axillary lymph nodes under imaging guidance to mark tissue intended for selective surgical removal. The Magseed Pro® marker is localised using the Sentimag® Gen3 system handheld probes and surgically removed within/from the target tissue.
- interventionNames
- Device: Magseed Pro(R) and Sentimag(R) Gen3 by Endomagnetics
- type
- OTHER
- label
- breast lesions requiring localisation
- description
- The Magseed Pro® marker is intended to be placed percutaneously in breast lesions under imaging guidance to mark tissue intended for selective surgical removal. The Magseed Pro® marker is localised using the Sentimag® Gen3 system handheld probes and surgically removed within/from the target tissue.
- interventionNames
- Device: Magseed Pro(R) and Sentimag(R) Gen3 by Endomagnetics
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available