Clinical trial NCT04569071: Clinical Trial of MgLiTT for Medical Refractory Epilepsy
Official title: A Multi-center Clinical Trial to Evaluate the Efficacy and Safety of MRI-guided Laser Interstitial Thermal Therapy for Medical Refractory Epilepsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Epilepsy
Keywords: Stereotactic surgery
Thermal ablation
Medical refractory epilepsy
Epilepsy surgery
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: Xuanwu Hospital, Beijing
name: Peking Union Medical College Hospital
name: Chinese PLA General Hospital
name: Peking University International Hospital
First posted: 2020-09-29
Enrollment: 110
Sex: ALL
Minimum age (years): 6
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: MgLiTT ablation rate
timeFrame: Within 3 days after operation
Secondary outcomes:
measure: Seizure free rate
timeFrame: 90±7 days after operation
measure: Seizure reduction rate
timeFrame: 90±7 days after operation
measure: Operation time
timeFrame: Within 1 day after operation
measure: Postsurgical hospitalization
timeFrame: Within 1 day after discharged from hospital
measure: Mini-Mental State Examination (MMSE) score
timeFrame: Before and 90±7 days after operation
measure: Quality of life in epilepsy-31 inventory (QOLIE-31) score
timeFrame: Before and 90±7 days after operation
measure: Quality of life in epilepsy for Adolescents (QOLIE-AD-48) score
timeFrame: Before and 90±7 days after operation
measure: Vital signs-body temperature
timeFrame: Before and 2±1 days after operation
measure: Vital signs-pulse
timeFrame: Before and 2±1 days after operation
measure: Vital signs-respiratory rate
timeFrame: Before and 2±1 days after operation
measure: Vital signs-blood pressure
timeFrame: Before and 2±1 days after operation
Other outcomes:
measure: Instrument performance evaluation
timeFrame: Within 1 day after operation
measure: The amount of bleeding
timeFrame: During operation
measure: Postsurgical complication rates
timeFrame: Within 1 day after discharged from hospital
measure: Failure free rate of laser ablation minimally invasive treatment kit
timeFrame: Within 1 day after operation
measure: Failure rate of magnetic resonance guided laser ablation system
timeFrame: Within 1 day after operation
measure: Incidence of adverse events and serious adverse events
timeFrame: Within 1 day after discharged from hospital
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Kai Zhang, Dr.
role: STUDY_DIRECTOR
References: