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Идёт набор NCT07465796

A First-in-Human Study of the CIPHER System During Brain Surgery for Newly Diagnosed Glioma

Без фазы С лечением Glioma Tumor Electrocorticography Brain

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: Electrocorticography for neural recording, Electrocorticography for neural recording and electrical stimulation.
Кому может быть актуально
Состояния в реестре: Glioma, Tumor, Electrocorticography, Brain. Базовые параметры: 18 лет — 75 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
Австралия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The goal of this clinical trial is to collect data on the use of the CIPHER System when used by a surgeon during brain tumor removal. The main questions it aims to answer are: * To evaluate the safety of the CIPHER System when used during brain tumor surgery (Primary) * To evaluate the function of the electrodes under recording and stimulating conditions during surgery (Secondary) Participants will undergo standard-of-care surgery to remove their tumor. Just before the tumor is removed, the CIPHER System will be tested on the main tumor and the surrounding margin areas. Participants will be monitored during standard hospital visits occurring during the recovery period after surgery as well as two- and six-weeks after surgery.

Подробное описание

Brain tumor resection surgery involves a balance between removing tumor and preserving healthy tissue. Current standard-of-care mapping tools use limited electrode configurations on rigid substrates to stimulate and record brain activity for identifying functional brain areas to avoid. A more flexible and high electrode-count tool to map the tumor characteristics based on spontaneous neural activity could strengthen surgical outcomes.

Emerging evidence also demonstrates that brain tumors, such as gliomas, are not biologically isolated but instead integrate functionally into neural circuits. Electrical stimulation-based strategies could provide novel treatment modalities that target the neural-tumour interactions and improve patient outcomes.

This clinical investigation is a First-in-Human exploratory study of the CIPHER System, including a novel highly flexible, electrode-dense thin-film cortical probe developed for neurophysiological mapping and stimulation during brain tumour resection surgery. The study is designed to evaluate the safety, basic performance, and handling characteristics of the CIPHER System during short-duration intraoperative use.

Вмешательства

  • Устройство Electrocorticography for neural recording
    Electrocorticography probe placed on the brain surface for neural recording
  • Устройство Electrocorticography for neural recording and electrical stimulation
    Electrocorticography probe placed on the brain surface for neural recording and electrical stimulation

Первичные конечные точки

  • Incidence of all device/procedure-related adverse events (safety and tolerability) relevant to the intended use of the study device [Срок оценки: From enrollment to the end of postoperative six-week follow-up visit]
Вторичные конечные точки (4)
  • Presence or absence of spontaneous neural activity on recording electrodes [Срок оценки: At enrollment]
  • Signal-to-noise ratio of recorded signals [Срок оценки: At enrollment]
  • Evaluate local field potential neural activity before and after stimulation [Срок оценки: At enrollment]
  • Incidence and characterization of device deficiencies during intraoperative use [Срок оценки: At enrollment]

Критерии участия

Критерии включения

  • Newly diagnosed supratentorial glioma requiring resection
  • Glioma mass reaches or close to cortical surface
  • Adults aged 18-75
  • Planned for open craniotomy under Total Intravenous Anesthesia (TIVA)
  • Patient able to provide informed consent
  • Performance status: Eastern Cooperative Oncology Group (ECOG) scale 0-2

Критерии исключения

  • Prior craniotomy at the same anatomical location
  • Plan for awake craniotomy
  • Any history of seizures prior to craniotomy
  • Any history of coagulopathy or coagulation disorders
  • Pregnant status during craniotomy

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Оценка устройства

Центры проведения

Австралия · 1 центр
  • The Royal Melbourne Hospital, Department of Neurosurgery 4 East — Melbourne

Идентификаторы

NCT: NCT07465796 · CL_CNS_00008 · HREC 474/25

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗