[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557057":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":37,"responsibleParty":130,"collaborators":20,"id":132,"slug":133,"hasResults":134,"nctId":135,"briefTitle":136,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":134,"sex":139,"minAge":140,"maxAge":20,"enrollmentInfo":141,"targetDuration":20,"studyType":144,"phases":145,"briefSummary":147,"conditions":148,"keywords":20,"overallStatus":40,"whyStopped":20,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},{"fullName":5,"class":6},"BioTex, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Device use","EXPERIMENTAL","This investigation will employ an individualized dose-time-escalation approach starting each patient at a low dose and escalating the dose within the same patient.\n\nFor each patient, the device will be used starting at 4 hours per day. If a patient doesn't experience any issues for 2 weeks, they would ramp up to 6 hours per day. After another 2 weeks without issues, they will increase to 8 hours per day and maintain that for the remainder of the study.\n\nIf a patient encounters any issues thought to probably be device related by the PI during any of the 2-week intervals at different doses, they will be reduced by 4 hours per day (with a minimum therapy of 2 hours per day) for a specified duration up to 2 weeks, although this can be adjusted based on symptoms at the investigator's discretion. Each patient will follow this personalized escalation pathway.",[13],"Device: Oncomagnetic device",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Oncomagnetic device","OncoMAGNETX has developed a portable wearable noninvasive magnetic device (Oncomagnetic device) for the treatment of GBM.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Frank Giordano, MD","Universitätsmedizin Mannheim | UMM","PRINCIPAL_INVESTIGATOR",[27,33],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Ashok Gowda","CONTACT","713-741-0111","201","ashok@biotexmedical.com",{"name":34,"role":29,"phone":30,"phoneExt":35,"email":36},"Madeline Meier","254","madeline.meier@biotexmedical.com",[38,57,72,87,101,116],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Clinical Center Stuttgart","RECRUITING","Stuttgart","Baden-Wurttemberg","70174","Germany","DE",{"type":47,"coordinates":48},"Point",[49,50],9.17702,48.78232,{"lat":50,"lon":49},[53],{"name":54,"role":29,"phone":55,"phoneExt":20,"email":56},"Marc Muenter","0049 0711\u002F278 33701","M.Muenter@klinikum-stuttgart.de",{"facility":58,"status":40,"city":59,"state":60,"zip":61,"country":44,"countryCode":45,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Technical University of Munich","München","Bavaria","81675",{"type":47,"coordinates":63},[64,65],13.46314,48.69668,{"lat":65,"lon":64},[68],{"name":69,"role":29,"phone":70,"phoneExt":20,"email":71},"Stephanie Combs","0049 894-140-4500","stephanie.combs@tum.de",{"facility":73,"status":40,"city":74,"state":75,"zip":76,"country":44,"countryCode":45,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"University Hospital Bonn","Bonn","North Rhine-Westphalia","53127",{"type":47,"coordinates":78},[79,80],7.09549,50.73438,{"lat":80,"lon":79},[83],{"name":84,"role":29,"phone":85,"phoneExt":20,"email":86},"Eleni Gkika","0049 2282 8710 352","Eleni.Gkika@ukbonn.de",{"facility":88,"status":40,"city":89,"state":75,"zip":90,"country":44,"countryCode":45,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Clinical Center Lünen","Lünen","44534",{"type":47,"coordinates":92},[93,94],7.52872,51.61634,{"lat":94,"lon":93},[97],{"name":98,"role":29,"phone":99,"phoneExt":20,"email":100},"Martin Glas","0049 201 7236507","Martin.Glas@uk-essen.de",{"facility":102,"status":40,"city":103,"state":104,"zip":105,"country":44,"countryCode":45,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"University Hospital Leipzig","Leipzig","Saxony","04103",{"type":47,"coordinates":107},[108,109],12.37129,51.33962,{"lat":109,"lon":108},[112],{"name":113,"role":29,"phone":114,"phoneExt":20,"email":115},"Clemens Seidel","0049 341 9718400","Clemens.Seidel@medizin.uni-leipzig.de",{"facility":117,"status":40,"city":118,"state":20,"zip":119,"country":44,"countryCode":45,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Medical Center Mannheim","Mannheim","68167",{"type":47,"coordinates":121},[122,123],8.46694,49.4891,{"lat":123,"lon":122},[126],{"name":127,"role":29,"phone":128,"phoneExt":20,"email":129},"Frank Giordano","0049 6213 8315 0049","frank.giordano@umm.de",{"type":131,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100557057","low-intensity-oscillatory-magnetic-therapy-in-patients-with-newly-diagnosed-glioblastoma-multiforme-gbm---an-exposure-time-escalation-pilot-trial-100557057",false,"NCT06533163","Low-Intensity Oscillatory Magnetic Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme (GBM) - An Exposure-time Escalation Pilot Trial","OMX-EFS-01","Inclusion Criteria:\n\n1. The subject is at least 18 years of age.\n2. The subject previously had maximal safe resection (MSR) for glioblastoma (GBM) per the discretion of the investigator and is able to receive standard radiotherapy (unless contraindicated or refused by the subject)\n3. The subject has a newly confirmed diagnosis of GBM per WHO classification criteria.\n4. The subject has pre-op, post-surgical MRI and RX planning MRI scans available for Investigator review.\n5. The subject has a confirmed unmethylated MGMT promoter status.\n6. The subject has a KPS ≥ 70.\n7. The subject's life expectancy is \\>12 weeks.\n8. The subject is no longer taking corticosteroids.\n9. The subject has signed and dated the consent form.\n10. The subject has stated understanding and willingness to comply with all clinical investigation procedures and availability for the duration of the clinical investigation.\n\nExclusion Criteria:\n\n1. The subject has a tumor in the brainstem, extensive or multicentric disease (e.g. in both hemispheres), or an abnormal regrowth pattern between the post operation MRI and RX planning MRI, suggesting early tumor progression, as determined by the Investigator's discretion.\n2. The subject is any of the following: pregnant, planning on becoming pregnant during the investigation, breastfeeding, incarcerated, or enrolled in another clinical investigation.\n3. The subject has a severe acute infection, any autoimmune disease, significant congenital anomaly, other co-morbidity, or medical problem or is taking immunosuppressant therapy (except Dexamethasone) within 90 days of anticipated device use for a condition that in the opinion of the Investigator and Sponsor precludes enrollment in the investigation.\n4. The subject has had a known focal or generalized seizure after surgery.\n5. The subject has implants or any condition preventing the patient from undergoing serial MRI scans.\n6. The patient has a skull defect (such as, missing bone with no replacement), bullet fragments or ferrous metals.\n7. The subject has an active implanted device (e.g., cardiac pacemakers, Vagus Nerve Stimulation \\[VNS\\], Deep Brain Stimulation \\[DBS\\], programmable shunts, etc.).\n8. The subject has any of the following lab results:\n\n   * ANC \\\u003C 1500 cells\u002Fmm3 or \\\u003C 1.5 x 10\\^9 \u002FL.\n   * Platelet count \\\u003C 100,000 cells\u002Fmm3.\n9. The subject has a history of any previous anti-tumor treatment for a brain tumor.\n10. The subject is currently being treated or has been treated with other investigational agents\u002Fdevices that may compromise the results of this investigation (as per discretion of the Investigator).\n11. The subject takes any nutritional supplements or alternative medical treatments that may compromise the results of this investigation (this is as per discretion of the Investigator, but any compound with anti-oxidant properties is strongly discouraged).\n12. The subject has planned concomitant or adjuvant chemotherapy.","ALL","18 Years",{"count":142,"type":143},30,"ESTIMATED","INTERVENTIONAL",[146],"NA","The clinical investigation is a non-randomized, multicenter, open-label, prospective, exposure-time escalation clinical investigation. The clinical investigation is designed to assess the clinical safety and performance of the Oncomagnetic Device.",[149],"Glioblastoma Multiforme","2026-05-29",{"date":152,"type":153},"2026-06-02","ACTUAL",{"date":155,"type":153},"2025-02-17",{"date":157,"type":143},"2028-04",{"name":5,"class":6},6]