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Safety and Feasibility of MR-guided Laser Thermal Ablation of Brain Lesions

Clinical Laserthermia Systems AB · 2022
ClinicalTrials.gov · Datasets · License: Public Domain · 2022
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glioblastoma
This will be an open-label, pilot, exploratory, single centre clinical investigation. This is an early feasibility single arm study. No formal hypothesis is proposed. A total of up to 15 evaluable subjects receiving a non-radical ablation is planned. The safety and feasibility outcomes will be measured directly post-treatment, 48h and 3 months post-treatment. A minimal invasive neurosurgical approach with a Magnetic Resonance Imaging (MRI)-based stereotactic guidance system will be utilized for the planning, navigation, intracranial access, placement and confirmation of the Laser applicator prior to ablation.
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