Epilepsy
Conditions
Interventions
Test group :Laser ablation
Sponsors
The Second Affiliated Hospital of Medical College of Zhejiang University
Eligibility
Sex/Gender
All
Age
2 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Age: 2 to 70 years old (including 2 and 70 years old), male and female; 2) Diagnosed as drug-refractory epilepsy; 3) The type of epileptic seizure was focal seizure; 4) The epileptogenic focus is limited and suitable for surgical treatment; 5) The subjects or their guardians can understand the purpose of the trial, voluntarily sign the informed consent form, and follow the clinical trial plan to cooperate with the examination and follow-up.
Exclusion criteria
Exclusion criteria: 1) MRI contraindication; 2) Change the epilepsy treatment plan within 3 months before operation; 3) There are contraindications for craniotomy; 4) Complicated with progressive nervous system disease; 5) Severe impairment of coagulation function; 6) Those who are in the acute stage of acute infection or chronic infection; 7) Pregnant or lactating women; 8) Those who have participated in clinical trials of other drugs or medical devices within one month before screening; 9) The patients with severe insufficiency of heart, liver and kidney function and the researchers think it is not suitable to participate in this clinical trial; 10) The researcher believes that it is not suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ablation efficiency; | — |
Secondary
| Measure | Time frame |
|---|---|
| Seizure-free rate;Percent reduction in seizures;Success rate of ablation technology;Quality of life score;Mini-Mental State Examination,MMSE;Evaluation of device performance;Postoperative hospital stay;Operation time;Incidence rate of adverse events and serious adverse events;Occurrence rate of device defects;Intraoperative bleeding volume;Success rate of optical fiber placement in place under software planning; | — |
Countries
China
Contacts
Public ContactZhangJianMing
The Second Affiliated Hospital of Medical College of Zhejiang University
Outcome results
None listed