Feasibility Study on LITT for Medical Refractory Epilepsy
Feasibility Study on LITT for Medical Refractory Epilepsy
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.
Relevant Inclusion Criteria are listed below

 -  Diagnosis of unilateral medial temporal lobe epilepsy (MTLE) confirmed clinically and
 with either (1) ictal scalp recording and MRI evidence of mesial temporal sclerosis or
 (2) intracranial ictal onset consistent with hippocampal origin

 -  Averages 1 or more complex partial seizures or secondary generalized seizures
 compatible with MTLE per month

 -  On stable antiepileptic medications

 -  Meets the criteria for a medial temporal lobe resection and is a candidate for LITT

 -  18 years or older at the time of consent

 Relevant Exclusion Criteria are listed below

 -  Previous diagnosis of psychogenic/non-epileptic seizures

 -  Previous diagnosis of primary generalized seizures

 -  IQ less than 70

 -  Subject has a MRI-incompatible implanted electronic device or any metallic prosthesis
 or implant for which brain MRI is contraindicated