[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"spinal-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:spinal-tumors":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,59,86,117],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":33,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100640600","pmcf-study-on-the-effectiveness-and-safety-of-metrosan-spinal-systems-and-bonegraft-filling-materials-100640600",false,"NCT07615491","PMCF Study on the Effectiveness and Safety of METROSAN Spinal Systems and BONEGRAFT Filling Materials","A Prospective, Multi-Center, Observational Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Effectiveness and Safety of METROSAN Spinal Systems and BONEGRAFT Filling Materials Used in Spinal Instrumentation and Fusion Surgery","INFO SPINE","Inclusion Criteria:\n\n* 18 years of age or older.\n* Skeletally mature.\n* Male or female.\n* Undergone spinal surgery (cervical or thoracolumbar) for any indication under current medical practice.\n* Titania® spinal stabilization\u002Ffusion systems and\u002For BONEGRAFT® bone cements or BONEGRAFT® bone graft materials used during the operation.\n* No general health condition contraindicating surgery.\n* No legal restriction (military service, incarceration, or equivalent).\n* Provision of signed and dated Informed Consent Form (ICF)\n\nExclusion Criteria:\n\n* Participation in another interventional clinical investigation\n* Suspected or confirmed pregnancy\n* Morbid obesity\n* Neurological or psychiatric conditions preventing compliance with postoperative care and instructions\n* Active spinal or systemic infection\n* High fever or leukocytosis\n* Severe osteoporosis and\u002For disease affecting bone metabolism\n* Known allergy or hypersensitivity to PEEK, Titanium, or PMMA\n* Congenital abnormality, tumor, or other condition preventing secure implant fixation or likely to shorten implant useful life\n* Inadequate tissue coverage at the operative site\n* Legally restricted individuals (military personnel, prisoners, etc.)","ALL","18 Years",{"count":20,"type":21},561,"ESTIMATED","OBSERVATIONAL","This is a prospective, multi-center, observational Post-Market Clinical Follow-Up (PMCF) study designed to collect additional safety and clinical performance data on CE-marked Titania® spinal instrumentation and fusion systems, and Bonegraft® bone filling materials (synthetic bone grafts and bone cements). The study aims to evaluate short-term (12-month) safety and effectiveness, identify previously unknown side effects, monitor defined complications, and assess risks based on real-world evidence in patients undergoing spinal surgery. All investigated products are used within their intended purpose under routine clinical practice.",[25,26,27,28,29,30,31,32],"Degenerative Disc Disease (DDD)","Spinal Stenosis","Spondylolisthesis","Spinal Deformities","Spinal Tumors","Spinal Infections","Spinal Trauma","Vertebral Fractures",[34,35,36,37,38,39,40,41,42,43,44,45],"Post-Market Clinical Follow-Up (PMCF)","Spinal Instrumentation","Spinal Fusion","Interbody Fusion","Spinal Stabilization","Spinal Cages","Pedicle Screws","Cervical Plate System","Interspinous Fusion Device","Spinal Implants","Synthetic Bone Graft","Bone Cement","RECRUITING","2026-05-22",{"date":49,"type":50},"2026-05-29","ACTUAL",{"date":52,"type":50},"2026-04-27",{"date":54,"type":21},"2028-09-26",{"name":56,"class":57},"Metrosan End. ve Elk. Mek. Cihazlar ve Tibbi Malz. San. Tic. Ltd. Co.","INDUSTRY",3,{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":66,"targetDuration":4,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":85},"100625960","sbrt-technique-implementation-for-spinal-metastases-irradiation-100625960","NCT07429422","SBRT Technique Implementation for Spinal Metastases Irradiation","Program SBRT Technique Implementation in Spinal Metastases Irradiation","Inclusion Criteria:\n\n* Adult patients (≥18 years) with spinal metastases or spinal tumors referred for stereotactic body radiotherapy (SBRT).\n* Patients eligible for SBRT treatment according to the institutional SBRT spine protocol.\n* Ability to undergo CT simulation, immobilization, and image-guided radiotherapy procedures.\n\nExclusion Criteria:\n\n* Inability to tolerate SBRT positioning or immobilization.\n* Clinical situations requiring urgent surgical intervention or alternative treatment.\n* Other medical conditions that prevent safe SBRT delivery.",{"count":67,"type":21},100,"INTERVENTIONAL",[70],"NA","Stereotactic body radiotherapy (SBRT) is a highly precise, image-guided radiotherapy technique delivering 1-5 high-dose fractions to spinal metastases. Compared with conventional radiotherapy, SBRT enables delivery of a higher biologically effective dose while maintaining high precision.\n\nThe Institute of Oncology Ljubljana initiated spinal SBRT treatments in 2017 and introduced an institutional SBRT spine protocol in 2019. As SBRT is technically demanding, strict adherence to standardized planning and delivery procedures is essential to ensure treatment quality and patient safety.\n\nThis clinical program aims to support structured implementation and continuous development of the institutional SBRT spine protocol in routine clinical practice. The study prospectively evaluates treatment-related toxicity and local tumor control following SBRT for spinal metastases in order to monitor treatment safety and effectiveness within the institutional program.",[73,29,74],"Spinal Metastases","Bone Metastases","2026-02-20",{"date":77,"type":50},"2026-02-24",{"date":79,"type":50},"2021-11-01",{"date":81,"type":21},"2026-12-31",{"name":83,"class":84},"Institute of Oncology Ljubljana","OTHER",2,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":68,"phases":96,"briefSummary":97,"conditions":98,"keywords":99,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":116},"100610197","liquid-biopsy-following-bbb-disruption-using-barrier-disrupting-fields-in-patients-undergoing-spine-surgery-100610197","NCT07224451","Liquid Biopsy Following BBB Disruption Using Barrier Disrupting Fields in Patients Undergoing Spine Surgery","Liquid Biopsy Following Blood-Brain Barrier Disruption Using Barrier Disrupting Fields in Patients Undergoing Spine Surgery","BDF002","Inclusion Criteria:\n\n* Adult subjects over the age of 18\n* Able to sign informed consent\n* Candidates for intradural tumor resection spinal surgery with intraoperative neuromonitoring.\n\nExclusion Criteria:\n\n* Pacemakers, or other implanted electric medical devices\n* Pregnant or lactating females\n* Major medical, neurologic or psychiatric condition who are judged as unable to fully comply with the study\n* History of skull fractures or previous brain surgery\n* American Society of Anesthesiologists grade \\>2\n* Anticoagulants treatment\n* Damage to the dura resulting in CSF leak\n* Patients with seizures\u002Fepilepsy",{"count":95,"type":21},20,[70],"Objective: To identify new central nervous system (CNS) biomarkers to be used for blood-derived liquid biopsy once the blood-brain barrier (BBB), specifically the blood-arachnoid barrier (BAB), has been transiently disrupted by BDF in patients undergoing spine surgery.\n\nDesign: Single center (Sheba Medical Center), prospective, controlled. Phase: Feasibility study\n\nEndpoints:\n\nEfficacy The primary endpoint of the study is the elevation in blood concentration of CNS biomarkers following the study procedure compared to biomarkers detected in cerebrospinal fluid (CSF) of the same subject.\n\nSafety The primary safety endpoint will be the overall incidence of BDF procedure-related AEs and SAEs, with severity graded according to CTCAE v5.0 criteria.\n\nStudy population:\n\nThe study population will include up to 20 patients undergoing spine surgery.\n\nStudy period:\n\n24 months.\n\nInclusion criteria:\n\n1. Adult subjects over the age of 18\n2. Able to sign informed consent\n3. Candidates for intradural tumor resection spinal surgery with intraoperative neuromonitoring.\n\nExclusion criteria:\n\n1. Pacemakers, or other implanted electric medical devices\n2. Pregnant or lactating females\n3. Major medical, neurologic or psychiatric condition who are judged as unable to fully comply with the study\n4. History of skull fractures or previous brain surgery\n5. American Society of Anesthesiologists grade \\>2\n6. Anticoagulants treatment\n7. Damage to the dura resulting in CSF leak\n8. Patients with seizures\u002Fepilepsy\n\nStudy procedure:\n\n1. Candidates for intradural tumor resection spinal surgery with intraoperative neuromonitoring will be enrolled in the study prior to surgery.\n2. The patient will undergo preparation for surgery according to the standard care.\n3. Once anesthetized and intubated, electrodes will be attached to the patient's head.\n4. After placing the electrodes, when the patient is under anesthesia, a blood sample will be taken prior to BDF. This sample will be used as baseline for BDF.\n5. The patient will then undergo a BDF procedure.\n6. Additional blood samples will be taken for identification of CNS biomarkers.\n7. Surgery will then proceed according to the standard of care.\n8. Once the dura is opened, a CSF sample will be taken, in order to compare the blood biomarkers of the specific subject with the CSF biomarkers.\n9. The surgery will continue according to the standard of care.",[29],[100,101,102,103,104,105],"Barrier disrupting fields","pulse electrical fields","blood-brain barrier opening","blood-arachnoid barrier opening","liquid biopsy","spinal tumors","2025-11-03",{"date":108,"type":50},"2025-11-04",{"date":110,"type":50},"2025-10-16",{"date":112,"type":21},"2027-10",{"name":114,"class":115},"Sheba Medical Center","OTHER_GOV",1,{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":124,"targetDuration":126,"studyType":22,"phases":4,"briefSummary":127,"conditions":128,"keywords":130,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":116},"100582932","swiss-spinal-tumor-registry-swiss-str-100582932","NCT06869746","Swiss Spinal Tumor Registry (Swiss-STR)","SSTR","Inclusion Criteria:\n\n* Diagnosis of primary spinal tumor\n* Diagnosis of secondary (metastatic) spinal tumor\n* Indication for surgical treatment is present\n* Patient age: =\u002F\\>18 years\n\nExclusion criteria:\n\n* Withdrawal of consent\n* Withdrawal from initially planned surgical procedure\n* Patient age: \\\u003C18 years",{"count":125,"type":21},250,"2 Years","The Swiss Spinal Tumor Registry is a prospective REDCap-based registry, collecting data of surgically treated patients with primary and metastatic tumors of the spine.",[29,129],"Surgical Treatment",[131,132],"Spinal Tumor","Spinal Metastasis","2025-03-14",{"date":135,"type":50},"2025-03-19",{"date":137,"type":50},"2023-01-01",{"date":139,"type":21},"2032-12-31",{"name":141,"class":84},"Luzerner Kantonsspital"]