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Liquid Biopsy Following BBB Disruption Using Barrier Disrupting Fields in Patients Undergoing Spine Surgery

RecruitingNAAges 18 Years - anyAllSheba Medical Center
NCT07224451 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. Design: Single center (Sheba Medical Center), prospective, controlled. Phase: Feasibility study Endpoints: Efficacy 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. Safety 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. Study population: The study population will include up to 20 patients undergoing spine surgery. Study period: 24 months. Inclusion criteria:

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adult subjects over the age of 18 * Able to sign informed consent * Candidates for intradural tumor resection spinal surgery with intraoperative neuromonitoring. Exclusion Criteria: * Pacemakers, or other implanted electric medical devices * Pregnant or lactating females * Major medical, neurologic or psychiatric condition who are judged as unable to fully comply with the study * History of skull fractures or previous brain surgery * American Society of Anesthesiologists grade \>2 * Anticoagulants treatment * Damage to the dura resulting in CSF leak * Patients with seizures/epilepsy
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What it tests

  • spinal surgery
  • BDF
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Where

1 site
Sheba Medical Center
Ramat Gan, Israel
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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