MINDZ Subdural Electrode Grid First-in-Human Pilot Study NCT07543406
Summary
Neurosoft Bioelectronics registered a first-in-human pilot study (NCT07543406) for the MINDZ subdural electrode grid, an investigational medical device designed for minimally invasive burr hole implantation in neurosurgical settings. The study will generate initial clinical evidence on safety and functional performance to support future CE marking under the European Medical Device Regulation. Estimated enrollment is 50-100 participants.
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What changed
Neurosoft Bioelectronics registered a first-in-human clinical investigation for the MINDZ subdural electrode grid on ClinicalTrials.gov. The investigational device is a soft, conformable subdural electrode grid designed for minimally invasive implantation through a burr hole, intended to improve cortical surface conformity and reduce craniotomy-associated complication risks.
Affected parties include medical device manufacturers developing cortical electrode technologies, clinical investigators conducting neurosurgical studies, and hospitals performing intraoperative neurophysiological monitoring. Sponsors planning similar device submissions should note the study design references EU MDR conformity assessment as the intended regulatory pathway.
Archived snapshot
Apr 22, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
MINDZ-- Minimally Invasive Approach Pilot Study
N/A NCT07543406 Kind: NA Apr 21, 2026
Abstract
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.
Conditions: Intraoperative Neurophysiological Monitoring
Interventions: MINDZ Subdural Electrode Grid
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