Clinical Laserthermia Systems AB (publ) (CLS), which develops advanced innovative products for high-precision image guided laser ablation, announces that it has entered into an agreement with Skåne University Hospital to sponsor a clinical trial evaluating the safety and feasibility of magnetic resonance (MR) guided laser interstitial thermal therapy (MRgLITT) for ablation of glioblastoma lesions, using the CLS TRANBERG® Thermal Therapy System with Thermoguide™ Workstation. Approval for this trial has been obtained from the Swedish Medical Product Agency.
The single-center, single-arm prospective study will investigate the safety and feasibility of using a minimally invasive MR guided laser-based procedure to remove as much of the glioblastoma lesion as possible in five patients.
“I am more than pleased to announce this clinical collaboration with Skåne University Hospital within the field of neurosurgery. The collaboration includes a clinical investigation studying the safety and feasibility of using our TRANBERG® Thermal Therapy System with Thermoguide™ Workstation in MR guided LITT treatment in five patients with glioblastoma. It is also CLS start on collecting clinical evidence allowing us to apply for a class III CE-mark expansion of our sterile disposable TRANBERG® laser applicators for use in ablation of brain lesions”, says Dan J. Mogren, acting CEO of CLS.
Glioblastoma is the most aggressive type of brain tumor. About 50 000 new cases are reported each year in Europe and US combined, most of them progress despite treatment. Although intensive research and drug development is done and ongoing for the treatment of this disease, it remains almost incurable. Localization of the tumor may limit the use of traditional surgery and other local treatment options and are therefore deemed unsuccessful.
As the third largest hospital in Sweden, Skåne University Hospital offers a full range of highly specialised care, research and education. Skåne University Hospital has units in both Malmö and Lund, where a total of 12,000 employees belonging to more than 100 different professions and occupations work. We provide highly specialised care, and we are the national specialised medical care centre in four areas. Research at Skåne University Hospital is closely tied to point-of-care treatment and done in co-operation with Lund University. We teach and supervise students who will eventually become our colleagues in the future. Students of all professional categories (physiotherapists, registered nurses, social workers, doctors, practical nurses, etcetera) receive their clinical training (VFU) with us.
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