Feasibility Study on LITT for Medical Refractory Epilepsy
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Feasibility Study on Laser Interstitial Thermal Therapy Ablation for the Treatment of Medical Refractory Epilepsy (FLARE)|
- Adverse events [ Time Frame: 2 Years ]Characterize adverse events experienced in medial temporal lobe epilepsy subjects undergoing LITT using the NeuroBlate System. Adverse events will be collected based on subject reports and subject examination/testing.
- Changes in neuropsychological functioning [ Time Frame: 1 Year ]Characterize changes to neuropsychological functioning experienced in medial temporal lobe epilepsy subjects undergoing LITT using the NeuroBlate System. Descriptive statistics (via neuropsychological assessment tools) will be reported for the measured score at baseline and each follow-up visit.
- Changes in seizure frequency [ Time Frame: 2 Years ]Characterize changes in seizure frequency experienced in medial temporal lobe epilepsy subjects undergoing LITT using the NeuroBlate System by utilizing patient diary to evaluate seizure occurrences.
- Surgical outcome classification [ Time Frame: 2 Years ]Characterize the Engel and ILAE surgical outcome classification in medial temporal lobe epilepsy subjects undergoing LITT using the NeuroBlate System. Classifications will be determined by the Investigator.
- Changes in quality of life [ Time Frame: 2 Years ]Characterize the changes in quality of life in subjects with medical temporal lobe epilepsy undergoing LITT using the NeuroBlate System. Quality of life will be measured using the QOLIE-31 questionnaire.
|Study Start Date:||August 2016|
|Estimated Study Completion Date:||December 2019|
|Estimated Primary Completion Date:||December 2019 (Final data collection date for primary outcome measure)|
NeuroBlate LITT Treatment
This is a single arm study. All eligible study subjects will undergo LITT with the NeuroBlate System.
Device: NeuroBlate System
Laser Interstitial Thermal Therapy
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 enter a Baseline (pre-surgery) Phase to establish their baseline seizure frequency. Subjects, or their caregivers, are required to keep a seizure diary throughout the study, beginning at the first baseline visit. The study will monitor and record subjects' seizure frequency, antiepileptic medications, and physical and emotional health.
Upon demonstrating the required seizure frequency and stable antiepileptic medications for the 3-Month Baseline Phase, subjects will qualify for the study procedure. 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02820740
|Contact: Joan Hazenemail@example.com|
|Contact: Audrey Singhfirstname.lastname@example.org|