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CLS today announced that the first patient has been safely treated in the clinical trial at Skåne University Hospital (SUS) aiming to evaluate MR-guided Laser Interstitial Thermal Therapy (MRg LITT) for glioblastoma ablation. The CLS sponsored study at Skåne University Hospital is a single-center, single-arm, prospective clinical trial, with the aim to evaluate safety and feasibility of using minimally invasive MRgLITT in brain, for ablation of tumor tissue in patients diagnosed with glioblastoma.
The team at Skåne University Hospital utilizes CLS’s latest thermal therapy product branded ClearPoint PrismTM Neuro Laser Therapy System, in combination with ClearPoint® Neuro Navigation System, to perform the MRg LITT procedure.
“The clinical trial with minimally invasive laser thermal treatment of patients with recurrent malignant brain tumors, 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 suite to avoid transporting the patient between surgery and the MRI-suite” stated Dr. Peter Siesjö, Neurosurgeon and principal investigator of the study at Skåne University Hospital.
“CLS is excited that this significant milestone has been reached in our clinical study investigating the use of our product in MRg- LITT for ablation of glioblastoma, a study that is conducted in collaboration with the department of neurosurgery at Skåne University Hospital here in Lund in Sweden. The aim of the study is to provide initial data for CLS planned CE marking of the product in Europe”, stated Dan J. Mogren, CEO of Clinical Laserthermia Systems AB.
In September of this year CLS received US-FDA marketing clearance for the ClearPoint PrismTM Neuro Laser Therapy System, for use in neurosurgery, in USA. The product is commercialized through CLS´ global distributor ClearPoint Neuro Inc.
Read more about the FDA-clearance and our collaboration with ClearPoint Neuro within neurosurgery here.
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