University Hospital Zurich
Zurich, Switzerland
NCT Number: NCT07543406
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.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Not applicable
Zurich, Switzerland
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 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
Time frame: up to 7 days post-intervention
User-reported device usability, assessed via questionnaire completed by each participating neurosurgeon following the intervention
Time frame: up to 7days post-intervention
Operator-reported ratings of haptic feedback during insertion and deployment, collected via questionnaire (e.g., force perception, resistance, and tactile response)
Time frame: during intraoperative procedure
Time frame: during intraoperative procedure
Contact information is provided by the study sponsor or research team.
Neurosoft Bioelectronics SA
Industry
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
Acronym: MINDZ-MAP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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