[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Neurosoft Bioelectronics SA\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":77},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100634724","mindz---minimally-invasive-approach-pilot-study-100634724",false,"NCT07543406","MINDZ-- Minimally Invasive Approach Pilot Study","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","MINDZ-MAP","Inclusion Criteria:\n\n* Age ≥18 and ≤75 years at the time of enrolment.\n* 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)\n* Participants capable and willing to provide informed consent for participation in the trial.\n\nExclusion Criteria:\n\n* History of significant psychiatric impairments which, in the opinion of the investigator, will interfere with the proper administration or completion of the protocol.\n* 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).\n* Participation in another clinical study.\n* Known intolerances to the materials used in the soft device (medical grade silicone or platinum).\n* Vulnerable subject groups (e.g., pregnancy or lactation, prisoners, etc.).\n* 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.","ALL","18 Years","75 Years",{"count":21,"type":22},5,"ESTIMATED","INTERVENTIONAL",[25],"NA","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).\n\nThe 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.",[28],"Intraoperative Neurophysiological Monitoring",[30,31],"cortical electrode","IONM","NOT_YET_RECRUITING","2026-04-15",{"date":35,"type":36},"2026-04-21","ACTUAL",{"date":38,"type":22},"2026-05-01",{"date":40,"type":22},"2027-06-01",{"name":42,"class":43},"Neurosoft Bioelectronics SA","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":44},"100531850","evaluation-of-new-flexible-high-density-intra-operative-ecog-electrodes-for-epilepsy-surgery--epigrid--100531850","NCT06205160","Evaluation of New Flexible High-density Intra-operative ECoG Electrodes for Epilepsy Surgery. ( EpiGrid )","The EpiGrid Study Evaluation of New Flexible High-density Intra-operative ECoG Electrodes for Epilepsy Surgery","EpiGrid","Inclusion Criteria:\n\n* Age ≥18 years at the time of enrolment\n* Lesional epilepsy (incl. secondary mesial temporal sclerosis) that is considered a candidate for intra-operative high-density grid recordings (incl. patients who underwent sEEG preceding resective surgery)\n* Provided informed consent for study participation by the subject\n\nExclusion Criteria:\n\n* Occipital lesion\n* Surgeries involving a primary mesial temporal lesion, a disconnection, or hemispherectomy.\n* Planned ioECoG recordings during fully awake surgery and\u002For functional recordings\n* Use of anticoagulants that cannot be discontinued during the perioperative period, or a factor XIII deficiency or any other haematological disease\n* Active participation in another investigational device study\n* Any other condition that in the opinion of the investigator may adversely affect the safety of the subject or would limit the subject's ability to complete the study.\n* Insufficient understanding of Dutch language.",{"count":54,"type":22},12,[25],"The objective of this prospective interventional monocentric clinical investigation is to evaluate the feasibility and performance of the flexible high-density SOFT ECoG electrode grids, manufactured by Neurosoft Bioelectronics SA (test device; TD), in comparison to regular high-density electrode grids (ADTech, CE-marked) (control device; CD) routinely used at the investigation site during epilepsy surgery.\n\nSubjects will undergo ≥ 2 additional intracranial recordings pre- and post-resection with the TD next to the standard recordings with the CD during ECoG-tailored epilepsy surgery.",[58,59],"Focal Epilepsy","Intraoperative Monitoring",[61,62,63,64,65,66,67],"intra-operative electrocorticography","HFO","epileptic biomarkers","high frequency oscillations","epilepsy surgery","flexible ECoG","subdural electrode","RECRUITING","2025-12-09",{"date":71,"type":36},"2025-12-10",{"date":73,"type":36},"2025-01-01",{"date":75,"type":22},"2027-03",{"name":42,"class":43},""]