Sponsored by Clinical Laserthermia Systems (CLS), the Safety and Feasibility of Magnetic Resonance (MR)-guided Laser Thermal Ablation of Brain Lesions study will evaluate the ClearPoint Prism Neuro Laser Therapy System.
The prospective single-centre, single-arm clinical trial has been designed to assess the feasibility and safety of using the minimally invasive MR-guided system for ablating tumours in up to five patients with glioblastoma.
The ClearPoint Prism Neuro Laser Therapy System has been indicated for use to necrotise or coagulate soft tissue using interstitial irradiation or thermal therapy under the guidance of magnetic resonance imaging (MRI) in neurosurgery.
It includes a clinical solution that combines the ClearPoint navigation platform with a thermal ablation monitoring software, known as Thermoguide, from Image Guided Therapy (IGT), which is based in Bordeaux, France.
The company holds the exclusive global rights for the commercialisation of the system by CLS for neuro applications.
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.”
CLS will use the data from the glioblastoma clinical trial to seek CE Mark for the system in Europe.