MINDZ-- Minimally Invasive Approach Pilot Study

Официальное название

MINDZ-- Minimally Invasive Approach Pilot Study Single Center, First-in-Human Evaluation of MINDZ Electrode- Demonstrating the Feasibility of Safe, Burr-hole Deployment and Functional Efficacy

Обзор

This clinical investigation is a pilot, first-in-human (FIH) study designed to demonstrate proof of concept, safety, and functional performance of the MINDZ subdural electrode grid when used in relevant neurosurgical settings. The study will provide initial clinical evidence to support future conformity assessment and CE marking under the European Medical Device Regulation (MDR). The investigational device, MINDZ, developed by Neurosoft Bioelectronics, is a novel, soft and highly conformable subdural electrode grid designed for minimally invasive implantation through a burr hole. Its flexible structure is intended to improve conformity to the cortical surface, reduce dead space between the electrode and brain tissue, and potentially lower the risk of complications associated with craniotomy, while maintaining adequate cortical coverage for effective monitoring and mapping.

Вмешательства

• Устройство MINDZ Subdural Electrode Grid
  The study intervention is limited to the insertion of the investigational device through the burr hole (up to 15 minutes), followed by an additional 5-minute recording using the device, resulting in a total extension of approximately 20 minutes to the standard surgical procedure. The data recorded using the investigational device will not be used for clinical decision-making. Following completion of the recording, the device will be removed through the burr hole, and the surgery will proceed ac

Первичные конечные точки

• Safety of the MINDZ Subdural Electrode Grid [Срок оценки: during the intraoperative procedure and up to 30days follow up]
• Functional Performance of the MINDZ Subdural Electrode Grid [Срок оценки: during the intraoperative procedure (post-deployment)]

Вторичные конечные точки (4)

• Usability [Срок оценки: up to 7 days post-intervention]
• Evaluation of haptic feedback during insertion and deployment [Срок оценки: up to 7days post-intervention]
• Procedural time assessment [Срок оценки: during intraoperative procedure]
• Technical difficulties and device deficiencies (DDs) [Срок оценки: during intraoperative procedure]

Критерии участия

Критерии включения

• Age ≥18 and ≤75 years at the time of enrolment.
• Patients diagnosed with a brain tumour or epilepsy who require neurosurgical intervention. This includes patients undergoing craniotomy for brain surgery without the need for intracranial electrode monitoring, as well as patients undergoing neurosurgery with intraoperative neurophysiological monitoring using subdural electrodes. Specifically, this includes patients for whom subdural strip electrodes are indicated and planned to be implanted through standard-size burr holes (e.g., for phase-reversal evaluation)
• Participants capable and willing to provide informed consent for participation in the trial.

Критерии исключения

• History of significant psychiatric impairments which, in the opinion of the investigator, will interfere with the proper administration or completion of the protocol.
• Any medical condition that contradicts neurosurgical intervention (i.e., acute or ongoing untreated infections, anticoagulant medication that cannot be discontinued, factor XIII deficiency or any other hematological disease).
• Participation in another clinical study.
• Known intolerances to the materials used in the soft device (medical grade silicone or platinum).
• Vulnerable subject groups (e.g., pregnancy or lactation, prisoners, etc.).
• Any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.

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

Оценка устройства

Центры проведения

Швейцария · 1 центр

• University Hospital Zurich — Zurich

Идентификаторы

NCT: NCT07543406 · CIP-04012

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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