NCT02820740

Feasibility Study on LITT for Medical Refractory Epilepsy

Feasibility Study on Laser Interstitial Thermal Therapy Ablation for the Treatment of Medical Refractory Epilepsy (FLARE)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Monteris Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DEVICE	NeuroBlate System	Laser Interstitial Thermal Therapy

Timeline

• Start date: 2017-04-21
• Primary completion: 2019-06-24
• Completion: 2019-06-24
• First posted: 2016-07-01
• Last updated: 2024-07-12
• Results posted: 2024-07-12

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study