A Multi-center Clinical Trial to Evaluate the Efficacy and Safety of MRI-guided Laser Interstitial Thermal Therapy for Medical Refractory Epilepsy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- MgLiTT ablation rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
MgLiTT ablation rate
时间窗: Within 3 days after operation
Measurement of postsurgical MRI
次要结局
- Seizure free rate(90±7 days after operation)
- Seizure reduction rate(90±7 days after operation)
- Operation time(Within 1 day after operation)
- Postsurgical hospitalization(Within 1 day after discharged from hospital)
- Mini-Mental State Examination (MMSE) score(Before and 90±7 days after operation)
- Quality of life in epilepsy-31 inventory (QOLIE-31) score(Before and 90±7 days after operation)
- Quality of life in epilepsy for Adolescents (QOLIE-AD-48) score(Before and 90±7 days after operation)
- Vital signs-body temperature(Before and 2±1 days after operation)
- Vital signs-pulse(Before and 2±1 days after operation)
- Vital signs-respiratory rate(Before and 2±1 days after operation)
- Vital signs-blood pressure(Before and 2±1 days after operation)