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
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Germany
Marienhospital Bottrop GmbH
RECRUITING
Bottrop
AGAPLESION Markus Frankfurter Diakonie Kliniken gGmbH
RECRUITING
Frankfurt
Technical University Munich
NOT_YET_RECRUITING
Munich
United Kingdom
Guy's Hospital
RECRUITING
London
Royal Marsden Hospital
RECRUITING
London
University Hospital South Manchester
RECRUITING
Manchester
Contact Information
Primary
Matt Womack, Dr
mwomack@endomag.com
+447851247439
Backup
Tanja Odeneg, Dr
todeneg@endomag.com
+441223652604
Time Frame
Start Date: 2023-03-02
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 224
Treatments
Other: axillary lymph nodes requiring localisation prior to surgical excision
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.
Other: breast lesions requiring localisation
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.
Related Therapeutic Areas
Sponsors
Leads: Endomagnetics Ltd.