Back to resultsClinical Trial of MgLiTT for Medical Refractory Epilepsy
Primary Purpose
Epilepsy
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Sinovation Laser Ablation System
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring Stereotactic surgery, Thermal ablation, Medical refractory epilepsy, Epilepsy surgery
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.
Sites / Locations
- Beijing Tiantan Hospital, Capital Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sinovation Laser Ablation System treatment
Arm Description
Sinovation Laser Ablation System treatment
Outcomes
Primary Outcome Measures
MgLiTT ablation rate
Measurement of postsurgical MRI
Secondary Outcome Measures
Seizure free rate
Follow-up
Seizure reduction rate
Follow up
Operation time
Medical recording
Postsurgical hospitalization
Medical recording
Mini-Mental State Examination (MMSE) score
Range from 0 to 30; Lower score indicates worse cognitive impairment
Quality of life in epilepsy-31 inventory (QOLIE-31) score
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
For Adolescents; Range from 0 to 100; Higher score indicates better quality of life
Vital signs-body temperature
From medical recording; Centigrade
Vital signs-pulse
From medical recording; Times/minute
Vital signs-respiratory rate
From medical recording; Times/minute
Vital signs-blood pressure
From medical recording; Systolic pressure/diastolic pressure (mmHg)
Full Information
NCT ID
NCT04569071
First Posted
September 10, 2020
Last Updated
September 23, 2020
Sponsor
Beijing Tiantan Hospital
Collaborators
Xuanwu Hospital, Beijing, Peking Union Medical College Hospital, Chinese PLA General Hospital, Peking University International Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04569071
Brief Title
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
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 8, 2020 (Actual)
Primary Completion Date
May 8, 2021 (Anticipated)
Study Completion Date
February 8, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Tiantan Hospital
Collaborators
Xuanwu Hospital, Beijing, Peking Union Medical College Hospital, Chinese PLA General Hospital, Peking University International Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Stereotactic surgery, Thermal ablation, Medical refractory epilepsy, Epilepsy surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sinovation Laser Ablation System treatment
Arm Type
Experimental
Arm Description
Sinovation Laser Ablation System treatment
Intervention Type
Device
Intervention Name(s)
Sinovation Laser Ablation System
Intervention Description
In the present single arm study. All eligible subjects will undergo MgLiTT with the Sinovation Laser Ablation System.
Primary Outcome Measure Information:
Title
MgLiTT ablation rate
Description
Measurement of postsurgical MRI
Time Frame
Within 3 days after operation
Secondary Outcome Measure Information:
Title
Seizure free rate
Description
Follow-up
Time Frame
90±7 days after operation
Title
Seizure reduction rate
Description
Follow up
Time Frame
90±7 days after operation
Title
Operation time
Description
Medical recording
Time Frame
Within 1 day after operation
Title
Postsurgical hospitalization
Description
Medical recording
Time Frame
Within 1 day after discharged from hospital
Title
Mini-Mental State Examination (MMSE) score
Description
Range from 0 to 30; Lower score indicates worse cognitive impairment
Time Frame
Before and 90±7 days after operation
Title
Quality of life in epilepsy-31 inventory (QOLIE-31) score
Description
For adult; Range from 0 to 100; Higher score indicates better quality of life
Time Frame
Before and 90±7 days after operation
Title
Quality of life in epilepsy for Adolescents (QOLIE-AD-48) score
Description
For Adolescents; Range from 0 to 100; Higher score indicates better quality of life
Time Frame
Before and 90±7 days after operation
Title
Vital signs-body temperature
Description
From medical recording; Centigrade
Time Frame
Before and 2±1 days after operation
Title
Vital signs-pulse
Description
From medical recording; Times/minute
Time Frame
Before and 2±1 days after operation
Title
Vital signs-respiratory rate
Description
From medical recording; Times/minute
Time Frame
Before and 2±1 days after operation
Title
Vital signs-blood pressure
Description
From medical recording; Systolic pressure/diastolic pressure (mmHg)
Time Frame
Before and 2±1 days after operation
Other Pre-specified Outcome Measures:
Title
Instrument performance evaluation
Description
Higher score indicates better instrument performance
Time Frame
Within 1 day after operation
Title
The amount of bleeding
Description
Medical recording
Time Frame
During operation
Title
Postsurgical complication rates
Description
Medical recording
Time Frame
Within 1 day after discharged from hospital
Title
Failure free rate of laser ablation minimally invasive treatment kit
Description
Medical recording
Time Frame
Within 1 day after operation
Title
Failure rate of magnetic resonance guided laser ablation system
Description
Medical recording
Time Frame
Within 1 day after operation
Title
Incidence of adverse events and serious adverse events
Description
Medical recording
Time Frame
Within 1 day after discharged from hospital
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kai Zhang, Dr.
Phone
+86 13501196619
Email
zhangkai62035@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiu Wang, Dr.
Phone
+86 13520908011
Email
wang19001@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kai Zhang, Dr.
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Tiantan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100070
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kai Zhang
Phone
+86 13501196619
Email
zhangkai62035@sina.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
We may only share clinical information (rather privacy information) in academic or other reasonable request.
IPD Sharing Time Frame
After the clinical trials.
IPD Sharing Access Criteria
reasonable requests.
Learn more about this trial
Clinical Trial of MgLiTT for Medical Refractory Epilepsy
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