MINDZ-- Minimally Invasive Approach Pilot Study (NCT07543406) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
MINDZ-- Minimally Invasive Approach Pilot Study
Switzerland5 participantsStarted 2026-05-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 infl…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety of the MINDZ Subdural Electrode Grid
Timeframe: during the intraoperative procedure and up to 30days follow up
2
Functional Performance of the MINDZ Subdural Electrode Grid
Timeframe: during the intraoperative procedure (post-deployment)