Magseed Pro(R)/ Sentimag(R) Gen3

NCT05142787 | Recruiting

• 1 other identifier: EU001
• Study Type: interventional
• Target: 224
• Locations: 2 countries
• Sites: 6

Brief 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

Conditions

Breast Cancer

Keywords

Magseed Pro; Sentimag Gen3

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  time of surgery

Secondary Outcomes (27)

• Tissue response (unexpected and expected)

  time of surgery

• Presence of unexpected histological tissue response for short- and long-term use of Magseed Pro marker

  time of surgery

• Rate of device-related AE's and SAE's

  through study completion, an average of 38 weeks

• Retrieval rate for all lesions

  time of surgery

• Retrieval rate for all nodes

  time of surgery

Study Arms (2)

axillary lymph nodes requiring localisation prior to surgical excision

OTHER

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.

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

breast lesions requiring localisation

OTHER

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.

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

Interventions

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

placement of Magseed Pro \& localisation with Sentimag Gen3 in axillary lymph nodes and/or breast lesions

axillary lymph nodes requiring localisation prior to surgical excision; breast lesions requiring localisation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Endomagnetics Ltd.: lead

Study Sites (6)

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

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Stefan Paepke, Dr

  The technical university of Munich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matt Womack, Dr

CONTACT

+447851247439; mwomack@endomag.com

Tanja Odeneg, Dr

CONTACT

+441223652604; todeneg@endomag.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: December 3, 2021
• Study Start: March 2, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3); GB (3)