Epilepsy Clinical Trial
Official title:
Feasibility Study on Laser Interstitial Thermal Therapy Ablation for the Treatment of Medical Refractory Epilepsy (FLARE)
Multicenter, open-label, prospective designed study to characterize the performance of brain laser interstitial thermal therapy (LITT) ablation using the Monteris NeuroBlate System for the treatment of drug-refractory medial temporal lobe epilepsy in subjects who are candidates for LITT surgery.
Monteris is sponsoring this multicenter, open-label, prospective feasibility study to
characterize the performance of laser interstitial thermal therapy (LITT) using the Monteris
NeuroBlate System for the treatment of drug-refractory medial temporal lobe epilepsy in
subjects who are candidates for LITT surgery.
The NeuroBlate System uses precise, high-intensity laser light to initiate necrosis of
abnormal brain tissue through thermal ablation while limiting injury to healthy tissue.
Unlike traditional brain surgery, LITT does not require a large opening in the skull.
Subjects who meet the study eligibility criteria and sign the informed consent form will
undergo the LITT procedure. Subjects, or their caregivers, are required to keep a seizure
diary throughout the study, beginning after surgery. The study will monitor and record
subjects' seizure frequency, antiepileptic medications, and physical and emotional health.
Subjects treated with NeuroBlate will have 2 years of follow-up. Throughout study
participation, the study investigator will continuously monitor and document both
effectiveness and safety data at study appointments.
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