ClearPoint recruits first patient in Glioblastoma study of its laser therapy system

2022-12-13

临床研究放射疗法

The study, dubbed Safety and Feasibility of MR-guided Laser Thermal Ablation of Brain Lesions, is a single-arm clinical trial that evaluates the safety and feasibility of the ClearPoint Prism Neuro Laser Therapy System ClearPoint Prism Neuro laser therapy system. (Credit: ClearPoint Neuro, Inc.) ClearPoint Neuro has recruited the first patient in a clinical trial conducted at Skåne University Hospital in Lund, Sweden, which uses ClearPoint Prism Neuro Laser Therapy System. The study, dubbed Safety and Feasibility of MR-guided Laser Thermal Ablation of Brain Lesions, is sponsored by Swedish medical device company Clinical Laserthermia Systems (CLS). It is a single-arm clinical trial evaluating the safety and feasibility of the minimally-invasive MR-guided laser therapy system to ablate tumours in up to five Glioblastoma patients. The team at SUS Lund is currently using the ClearPoint Neuro Navigation platform for the standard of care procedures. The procedures include tumour biopsy and guiding implantation of deep brain stimulation (DBS) electrodes to target. ClearPoint Neuro president and CEO Joe Burnett said: “We are proud to support SUS Lund and CLS on this pilot study using the innovative laser therapy system to treat glioblastoma lesions. “The ClearPoint Neuro Navigation System offers an efficient one-room solution that helps neurosurgeons in the United States to accurately place laser fibres and help treat brain tumours, radiation necrosis and epileptic foci in thousands of patients. “Expanding brain and spine laser therapy treatment options for patients and neurosurgeons in the EU, and beyond, is a key priority in the years ahead.” ClearPoint Neuro has obtained the exclusive global rights to ClearPoint Prism Neuro Laser Therapy System from CLS, for neuro applications. The system comprises a clinical solution that combines the ClearPoint navigation platform, and Thermoguide software. ClearPoint navigation platform is laser technology from CLS, and Thermoguide is a thermal ablation monitoring software from French medical device maker Image Guided Therapy. In September this year, CLS secured regulatory approval for the ClearPoint Prism Neuro Laser Therapy System from the US FDA. CLS intends to use the data from the clinical trial to pursue the CE mark for the ClearPoint Prism Neuro laser therapy system in Europe. Skåne University Hospital neurosurgeon and study principal investigator Peter Siesjö said: “The clinical trial with minimally invasive laser thermal treatment of patients with recurrent malignant brain tumours, glioblastoma, has now started at Skåne University Hospital and the treatment of the first patient could be carried out as planned. “The treatment was performed, for the first time in Sweden, in a magnetic resonance imaging (MRI) suite in order to avoid transporting the patient between surgery and the MRI suite.”

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