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NOT YET RECRUITING
NCT07543406
NA

MINDZ-- Minimally Invasive Approach Pilot Study

Sponsor: Neurosoft Bioelectronics SA

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

5

Start Date

2026-10-01

Completion Date

2027-09-01

Last Updated

2026-09-10

Healthy Volunteers

No

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 according to the standard clinical protocol.

Locations (1)

University Hospital Zurich

Zurich, Switzerland