Clinical Trial of MgLiTT for Medical Refractory Epilepsy

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04569071
Study type	Interventional
Source	Beijing Tiantan Hospital
Contact	Kai Zhang, Dr.
Phone	+86 13501196619
Email	zhangkai62035@sina.com
Status	Recruiting
Phase	N/A
Start date	August 8, 2020
Completion date	February 8, 2022

View Details

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