Epilepsy
Conditions
Keywords
Stereotactic surgery, Thermal ablation, Medical refractory epilepsy, Epilepsy surgery
Brief 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.
Interventions
DEVICESinovation Laser Ablation System
In the present single arm study. All eligible subjects will undergo MgLiTT with the Sinovation Laser Ablation System.
Sponsors
Xuanwu Hospital, Beijing
Peking Union Medical College Hospital
Chinese PLA General Hospital
Peking University International Hospital
Beijing Tiantan Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MgLiTT ablation rate | Within 3 days after operation | Measurement of postsurgical MRI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postsurgical hospitalization | Within 1 day after discharged from hospital | Medical recording |
| Quality of life in epilepsy-31 inventory (QOLIE-31) score | Before and 90±7 days after operation | For adult; Range from 0 to 100; Higher score indicates better quality of life |
| Quality of life in epilepsy for Adolescents (QOLIE-AD-48) score | Before and 90±7 days after operation | For Adolescents; Range from 0 to 100; Higher score indicates better quality of life |
| Vital signs-body temperature | Before and 2±1 days after operation | From medical recording; Centigrade |
| Vital signs-pulse | Before and 2±1 days after operation | From medical recording; Times/minute |
| Vital signs-respiratory rate | Before and 2±1 days after operation | From medical recording; Times/minute |
| Vital signs-blood pressure | Before and 2±1 days after operation | From medical recording; Systolic pressure/diastolic pressure (mmHg) |
| Seizure free rate | 90±7 days after operation | Follow-up |
| Seizure reduction rate | 90±7 days after operation | Follow up |
| Operation time | Within 1 day after operation | Medical recording |
| Mini-Mental State Examination (MMSE) score | Before and 90±7 days after operation | Range from 0 to 30; Lower score indicates worse cognitive impairment |
Other
| Measure | Time frame | Description |
|---|---|---|
| Postsurgical complication rates | Within 1 day after discharged from hospital | Medical recording |
| Failure free rate of laser ablation minimally invasive treatment kit | Within 1 day after operation | Medical recording |
| Failure rate of magnetic resonance guided laser ablation system | Within 1 day after operation | Medical recording |
| Incidence of adverse events and serious adverse events | Within 1 day after discharged from hospital | Medical recording |
| The amount of bleeding | During operation | Medical recording |
| Instrument performance evaluation | Within 1 day after operation | Higher score indicates better instrument performance |
Countries
China
Contacts
Primary ContactKai Zhang, Dr.
Backup ContactXiu Wang, Dr.
Outcome results
None listed