Magseed Pro(R)/ Sentimag(R) Gen3
Recruiting · NCT05142787 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Magseed Pro(R) and Sentimag(R) Gen3 by Endomagnetics
What this trial is about
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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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)
Where it is running
6 locations listed.
- Marienhospital Bottrop GmbH - Bottrop, Germany
- AGAPLESION Markus Frankfurter Diakonie Kliniken gGmbH - Frankfurt, Germany
- Guy's Hospital - London, United Kingdom
- Royal Marsden Hospital - London, United Kingdom
- University Hospital South Manchester - Manchester, United Kingdom
- Technical University Munich - Munich, Germany