MINDZ-- Minimally Invasive Approach Pilot Study Single Center, First-in-Human Evaluation of MINDZ Electrode- Demonstrating the Feasibility of Burr-hole Deployment and Functional Efficacy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Safety of the MINDZ Subdural Electrode Grid
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
MINDZ Subdural Electrode Grid for Intraoperative Neurophysiological Monitoring
This is a single arm study with no comparator. The MINDZ subdural electrode will be used in addition to the standard of care work flow.
干预措施: MINDZ Subdural Electrode Grid (Device)
结局指标
主要结局
Safety of the MINDZ Subdural Electrode Grid
时间窗: during the intraoperative procedure and up to 30days follow up
Incidence of device-emergent adverse events (SADE and ADE), assessed during the intraoperative procedure, post-procedurally, up to hospital discharge, and at the 30-day follow-up call. Acceptance criterion: No SADEs or ADEs observed in any patient.
Functional Performance of the MINDZ Subdural Electrode Grid
时间窗: during the intraoperative procedure (post-deployment)
Device functionality following deployment, evaluated based on impedance measurements across all electrode contacts, assessed during the intraoperative procedure Acceptance criterion: Acceptable impedance values (\<30 kΩ) achieved in at least 75% of electrode channels
次要结局
- Usability(up to 7 days post-intervention)
- Evaluation of haptic feedback during insertion and deployment(up to 7days post-intervention)
- Procedural time assessment(during intraoperative procedure)
- Technical difficulties and device deficiencies (DDs)(during intraoperative procedure)