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Clinical Trial of MgLiTT for Medical Refractory Epilepsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04569071
Recruitment Status : Recruiting
First Posted : September 29, 2020
Last Update Posted : September 29, 2020
Sponsor:
Collaborators:
Xuanwu Hospital, Beijing
Peking Union Medical College Hospital
Chinese PLA General Hospital
Peking University International Hospital
Information provided by (Responsible Party):
Beijing Tiantan Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Epilepsy Device: Sinovation Laser Ablation System Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center Clinical Trial to Evaluate the Efficacy and Safety of MRI-guided Laser Interstitial Thermal Therapy for Medical Refractory Epilepsy
Actual Study Start Date : August 8, 2020
Estimated Primary Completion Date : May 8, 2021
Estimated Study Completion Date : February 8, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arms and Interventions
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Arm Intervention/treatment
Experimental: Sinovation Laser Ablation System treatment
Sinovation Laser Ablation System treatment
 Device: Sinovation Laser Ablation System
In the present single arm study. All eligible subjects will undergo MgLiTT with the Sinovation Laser Ablation System.


Outcome Measures
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Primary Outcome Measures :
  1. MgLiTT ablation rate [ Time Frame: Within 3 days after operation ]
    Measurement of postsurgical MRI


Secondary Outcome Measures :
  1. Seizure free rate [ Time Frame: 90±7 days after operation ]
    Follow-up

  2. Seizure reduction rate [ Time Frame: 90±7 days after operation ]
    Follow up

  3. Operation time [ Time Frame: Within 1 day after operation ]
    Medical recording

  4. Postsurgical hospitalization [ Time Frame: Within 1 day after discharged from hospital ]
    Medical recording

  5. Mini-Mental State Examination (MMSE) score [ Time Frame: Before and 90±7 days after operation ]
    Range from 0 to 30; Lower score indicates worse cognitive impairment

  6. Quality of life in epilepsy-31 inventory (QOLIE-31) score [ Time Frame: Before and 90±7 days after operation ]
    For adult; Range from 0 to 100; Higher score indicates better quality of life

  7. Quality of life in epilepsy for Adolescents (QOLIE-AD-48) score [ Time Frame: Before and 90±7 days after operation ]
    For Adolescents; Range from 0 to 100; Higher score indicates better quality of life

  8. Vital signs-body temperature [ Time Frame: Before and 2±1 days after operation ]
    From medical recording; Centigrade

  9. Vital signs-pulse [ Time Frame: Before and 2±1 days after operation ]
    From medical recording; Times/minute

  10. Vital signs-respiratory rate [ Time Frame: Before and 2±1 days after operation ]
    From medical recording; Times/minute

  11. Vital signs-blood pressure [ Time Frame: Before and 2±1 days after operation ]
    From medical recording; Systolic pressure/diastolic pressure (mmHg)


Other Outcome Measures:
  1. Instrument performance evaluation [ Time Frame: Within 1 day after operation ]
    Higher score indicates better instrument performance

  2. The amount of bleeding [ Time Frame: During operation ]
    Medical recording

  3. Postsurgical complication rates [ Time Frame: Within 1 day after discharged from hospital ]
    Medical recording

  4. Failure free rate of laser ablation minimally invasive treatment kit [ Time Frame: Within 1 day after operation ]
    Medical recording

  5. Failure rate of magnetic resonance guided laser ablation system [ Time Frame: Within 1 day after operation ]
    Medical recording

  6. Incidence of adverse events and serious adverse events [ Time Frame: Within 1 day after discharged from hospital ]
    Medical recording


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Months to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04569071


Contacts
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Contact: Kai Zhang, Dr. +86 13501196619 zhangkai62035@sina.com
Contact: Xiu Wang, Dr. +86 13520908011 wang19001@163.com

Locations
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China, Beijing
Beijing Tiantan Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100070
Contact: Kai Zhang    +86 13501196619    zhangkai62035@sina.com   
Sponsors and Collaborators
Beijing Tiantan Hospital
Xuanwu Hospital, Beijing
Peking Union Medical College Hospital
Chinese PLA General Hospital
Peking University International Hospital
Investigators
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Study Director: Kai Zhang, Dr. Beijing Tiantan Hospital
More Information
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Responsible Party: Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT04569071    
Other Study ID Numbers: HK593202002
First Posted: September 29, 2020    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We may only share clinical information (rather privacy information) in academic or other reasonable request.
Supporting Materials: Analytic Code
Time Frame: After the clinical trials.
Access Criteria: reasonable requests.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Beijing Tiantan Hospital:
Stereotactic surgery
Thermal ablation
Medical refractory epilepsy
Epilepsy surgery
Additional relevant MeSH terms:
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Epilepsy
Drug Resistant Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases