Идёт набор NCT05142787

Magseed Pro(R)/ Sentimag(R) Gen3

Без фазы С лечением Breast Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Magseed Pro(R) and Sentimag(R) Gen3 by Endomagnetics.
Кому может быть актуально: Состояния в реестре: Breast Cancer. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Германия, Великобритания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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

Подробное описание

The Endomag Magseed Pro® Marker System is intended to be placed within the target soft tissue prior to planned surgical removal. The marker, when used in conjunction with the Sentimag® Gen 3 System, can be used as a guide for the surgeon to follow in the excision of tissue. The Sentimag® Gen3 Magnetic Localisation System when used with the Magseed family of markers is indicated to assist in localising soft tissue lesions.

The study design is a multicentre international prospective, open label, study of Magseed Pro® marker and Sentimag® Gen3 system in patients with breast and/or lymph node pathology with:

A. axillary lymph nodes requiring localisation prior to surgical excision (suspicious and/or biopsy proven lymph node or other pathology indicating removal) and/or B. breast lesions requiring localisation

Patients will have the Magseed Pro® marker placed to mark A. surgical excision of suspicious/biopsy-proven axillary lymph node as part of a targeted lymph node biopsy procedure AND/OR B. breast lesions in patients undergoing surgical excision of the targeted breast lesion The Magseed Pro® marker will be localised using the Sentimag® Gen3 system and therafter surgically removed with the target tissue.

This study will enrol 224 patients; 112 with Magseed Pro® marker placed to mark breast lesions and 112 with Magseed Pro® marker placed to mark nodes.

The expected duration of enrolment is approximately 9 months across all sites with each individual subject's participation lasting approximately 1-38 weeks after enrolment.

Вмешательства

Устройство 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

Первичные конечные точки

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 [Срок оценки: time of surgery]

Вторичные конечные точки (12)

Tissue response (unexpected and expected) [Срок оценки: time of surgery]
Presence of unexpected histological tissue response for short- and long-term use of Magseed Pro marker [Срок оценки: time of surgery]
Rate of device-related AE's and SAE's [Срок оценки: through study completion, an average of 38 weeks]
Retrieval rate for all lesions [Срок оценки: time of surgery]
Retrieval rate for all nodes [Срок оценки: time of surgery]
Per lesion retrieval rate for target excised specimens [Срок оценки: time of surgery]
Per lesion retrieval rate for all excised specimens [Срок оценки: time of surgery]
Per lesion retrieval rate for all lesion [Срок оценки: time of surgery]
Per lesion retrieval rate for all nodes [Срок оценки: time of surgery]
Per patient retrieval rate for Magseed Pro® marker placed prior to neo-adjuvant therapy and retrieved post neo-adjuvant therapy [Срок оценки: time of surgery]
Per lesion retrieval rate for Magseed Pro® marker placed prior to neo-adjuvant therapy and retrieved post neo-adjuvant therapy. [Срок оценки: time of surgery]
Per patient retrieval rate for Magseed Pro® marker where retrieval surgery is within 30 days of placement. [Срок оценки: time of surgery]

Критерии участия

Критерии включения

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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет