MINDZ-- Minimally Invasive Approach Pilot Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MINDZ Subdural Electrode Grid.
- Who it may be relevant to
- Registry conditions: Intraoperative Neurophysiological Monitoring. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Device 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
Primary outcome measures
- Safety of the MINDZ Subdural Electrode Grid [Time frame: during the intraoperative procedure and up to 30days follow up]
- Functional Performance of the MINDZ Subdural Electrode Grid [Time frame: during the intraoperative procedure (post-deployment)]
Secondary outcome measures (4)
- Usability [Time frame: up to 7 days post-intervention]
- Evaluation of haptic feedback during insertion and deployment [Time frame: up to 7days post-intervention]
- Procedural time assessment [Time frame: during intraoperative procedure]
- Technical difficulties and device deficiencies (DDs) [Time frame: during intraoperative procedure]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Device feasibility
Study locations
Switzerland · 1 center
- University Hospital Zurich — Zurich
Identifiers
NCT: NCT07543406 · CIP-04012