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Идёт набор NCT07206121

Feasibility Study for the SIRA-1000, SIRA® RFA Electrosurgical Device as an Adjunct to Breast Conserving Surgery

Без фазы С лечением Breast Cancer Breast-conserving Surgery Breast Cancer - Infiltrating Ductal Carcinoma ER/PR+Her2neu

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: Radiofrequency ablation alone, Radiofrequency ablation Electrosurgical Device.
Кому может быть актуально
Состояния в реестре: Breast Cancer, Breast-conserving Surgery, Breast Cancer - Infiltrating Ductal Carcinoma, ER/PR+Her2neu. Базовые параметры: от 50 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
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 Feasibility Study for the SIRA-1000, SIRA® RFA Electrosurgical Device as an Adjunct to Breast Conserving Surgery

Обзор

This study aims to assess the safety and clinical accuracy of the SIRA-1000, SIRA® RFA Electrosurgical Device in ablating margins post-lumpectomy in patients undergoing breast conserving surgery for breast cancer. Radiofrequency ablation, or RFA, uses radio waves to create heat, that in turn, causes deliberate controlled damage to the tissue surrounding where the tumor was located. You may hear your doctor refer to this as the 'margins'. Your doctor is using this treatment to help destroy remaining cancer cells in the margins around the site of the lump.

Подробное описание

During your surgery, after your lump is removed, the surgeon will place the SIRA-1000 in the breast cavity and perform the RF ablation procedure to treat the margins of the lumpectomy surgical site. A stitch will be used to stabilize and secure the tissue around the neck of the SIRA-1000 to ensure that contact is maintained between the SIRA-1000 electrode array and cavity tissue.

Upon completion of the RF ablation treatment, your tumor and the tissue samples from the ablated edges of the surgical site will be sent for review under a microscope (pathology).

After this, your surgery will be completed as standard, and your discharge will be determined by your medical team like any other surgery.

Вмешательства

  • Устройство Radiofrequency ablation alone
    Demonstrate the accuracy of the device to produce approximately 1 cm depth of ablation around the tumor bed, as evaluated by post-ablation tissue samples at least 1cm deep.
  • Устройство Radiofrequency ablation Electrosurgical Device
    SIRA-1000 an radiofrequency ablation device, is designed to fit the post-lumpectomy cavity to provide uniform ablation.

Первичные конечные точки

  • To assess the safety of SIRA-1000 by summarizing the occurrence of Adverse Events. [Срок оценки: The study will span a total of approximately 12 months with a follow-up for 5 years.]
  • Healing Process assessed by BREAST-Q Questionnaire [Срок оценки: 6 months]

Критерии участия

Критерии включения

  • Biologic female
  • 50 years of age and older
  • Confirmed diagnosis of breast cancer:
  • Infiltrating ductal carcinoma
  • ER/PR+Her2neu-
  • Grade I, II, or III
  • Unicentric, unilateral tumor size ≤ 3cm
  • Tumor location ≥ 2 cm from skin and other structures
  • Zubrod Performance Status of 0, 1, or 2
  • No palpable lymphadenopathy
  • Able and willing to provide written informed consent

Критерии исключения

  • Pregnant or breastfeeding
  • Neoadjuvant chemotherapy
  • Cardiac arrhythmia
  • Patients with active implantable medical devices, such as implanted cardiac pacemakers or defibrillators, or any other electronic device
  • Current or history of breast implants
  • Multi-centric or bilateral breast cancer
  • Diffuse microcalcifications
  • Participating in another ongoing clinical study in which concomitant diagnostic or therapeutic intervention that would reasonably be expected to alter the outcomes under study
  • Has a condition or is in a situation which in the Investigator's opinion may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

США · 1 центр
  • University of Texas Medical Branch at Galveston, TX — Galveston

Публикации

  • Klimberg VS, Ochoa D, Henry-Tillman R, Hardee M, Boneti C, Adkins LL, McCarthy M, Tummel E, Lee J, Malak S, Makhoul I, Korourian S. Long-term results of phase II ablation after breast lumpectomy added to extend intraoperative margins (ABLATE l) trial. J Am Coll Surg. 2014 Apr;218(4):741-9. doi: 10.1016/j.jamcollsurg.2013.12.032. Epub 2014 Jan 11. PMID 24655863

Идентификаторы

NCT: NCT07206121 · 28001-CSP

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗