NCT04569071

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 6 Months – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DEVICE	Sinovation Laser Ablation System	In the present single arm study. All eligible subjects will undergo MgLiTT with the Sinovation Laser Ablation System.

Timeline

• Start date: 2020-08-08
• Primary completion: 2021-05-08
• Completion: 2022-02-08
• First posted: 2020-09-29
• Last updated: 2020-09-29

Locations

1 site across 1 country: China