Clinical Trial of MgLiTT for Medical Refractory Epilepsy

A Multi-center Clinical Trial to Evaluate the Efficacy and Safety of MRI-guided Laser Interstitial Thermal Therapy for Medical Refractory Epilepsy

Multicenter, open-label, prospective designed study to characterize the performance of MRI-guided laser interstitial thermal therapy (MgLiTT) using the Sinovation Laser Ablation System for the treatment of medical refractory epilepsy.

The Sinovation Laser Ablation System uses robot-assisted, precise, high-intensity laser light to initiate necrosis of abnormal brain tissue through thermal ablation while limiting injury to adjacent healthy tissue. MgLiTT has the advantages of precision, minimal invasive procedure and real-time thermal monitoring.

Subjects who meet the study eligibility criteria and sign the informed consent form will undergo the MgLiTT 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 Sinovation Laser Ablation System will have at least 9 months of follow-up. Throughout study participation, the study investigator will continuously monitor and document both effectiveness and safety data at study appointments.

Inclusion Criteria:

• The age ranged from 6 months to 70 years old;
• Previous diagnosis of drug-resistant epilepsy with focal lesions;
• The average seizure frequency was more than 2 times/month within 3 months;
• Surgical treatment is suitable for epilepsy;
• The subjects or their guardians can understand the purpose of the trial, show adequate compliance with the trial protocol, and sign the informed consent form.

Exclusion Criteria:

• MRI contraindication;
• Patients with severe coagulation dysfunction;
• Pregnant or lactating women;
• Subjects who have participated in clinical trials of any other drugs or medical devices within 3 months;
• Evidence of severe or uncontrollable systemic diseases, as judged by the researchers;
• Subjects considered unsuitable for the clinical trial.