[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100531850":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":29,"responsibleParty":49,"collaborators":51,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":11,"enrollmentInfo":67,"targetDuration":11,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":32,"whyStopped":11,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Neurosoft Bioelectronics SA","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"All subjects","EXPERIMENTAL",null,[13],"Device: SOFT ECoG subdural grid electrode",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DEVICE","SOFT ECoG subdural grid electrode","Test Device (SOFT ECoG subdural grid electrode): used for recording. During epilepsy surgery, in addition to standard clinical protocol (recording with comparator device), subjects will undergo ≥ 2 additional intracranial recordings with the SOFT ECoG flexible high density electrode grid (TD). Recording will be registered pre- and post-resection.\n\nAll procedures will be conducted according to standard clinical practice. Any medical decision making will be done using the standard of care CE-marked device (CD). The investigational, non-CE marked device is not used for clinical decision making.",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Karolina Janikowska Clinical Affairs Manager, PhD","CONTACT","000 000-0000","karolina.janikowska@neurosoft-bio.com",{"name":27,"role":23,"phone":24,"phoneExt":11,"email":28},"G.J.M. Zijlmans Study Principal Investigator, PhD","G.J.M.Zijlmans@umcutrecht.nl",[30],{"facility":31,"status":32,"city":33,"state":11,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"University Medical Center (UMC) Utrecht","RECRUITING","Utrecht","3584CX","Netherlands","NL",{"type":38,"coordinates":39},"Point",[40,41],5.12222,52.09083,{"lat":41,"lon":40},[44,46],{"name":45,"role":23,"phone":11,"phoneExt":11,"email":11},"Maryse van 't Klooster Study Coordinator, PhD",{"name":47,"role":48,"phone":11,"phoneExt":11,"email":11},"Dr. G.J.M. (Maeike) Zijlmans Prof. Dr.","PRINCIPAL_INVESTIGATOR",{"type":50,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[52,55],{"name":53,"class":54},"UMC Utrecht","OTHER",{"name":56,"class":54},"European Research Council","100531850","evaluation-of-new-flexible-high-density-intra-operative-ecog-electrodes-for-epilepsy-surgery--epigrid--100531850",false,"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.","ALL","18 Years",{"count":68,"type":69},12,"ESTIMATED","INTERVENTIONAL",[72],"NA","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.",[75,76],"Focal Epilepsy","Intraoperative Monitoring",[78,79,80,81,82,83,84],"intra-operative electrocorticography","HFO","epileptic biomarkers","high frequency oscillations","epilepsy surgery","flexible ECoG","subdural electrode","2025-12-09",{"date":87,"type":88},"2025-12-10","ACTUAL",{"date":90,"type":88},"2025-01-01",{"date":92,"type":69},"2027-03",{"name":5,"class":6},1]