EpilepsyNCT04569071
Clinical Trial of MgLiTT for Medical Refractory Epilepsy
A study testing Sinovation Laser Ablation System in people with Epilepsy, run by Beijing Tiantan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 70 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Sinovation Laser Ablation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 8 Aug 2020to 8 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Kai Zhang, +86 13501196619, zhangkai62035@sina.com
About this study
Official title: A Multi-center Clinical Trial to Evaluate the Efficacy and Safety of MRI-guided Laser Interstitial Thermal Therapy for Medical Refractory Epilepsy
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.
Read the 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.
- Conditions
- Epilepsy
- Being tested
- Sinovation Laser Ablation System
- Keywords
- Stereotactic surgery, Thermal ablation, Medical refractory epilepsy, Epilepsy surgery
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinovation Laser Ablation SystemDevice
In the present single arm study. All eligible subjects will undergo MgLiTT with the Sinovation Laser Ablation System.
| Study group | Role | What they receive |
|---|---|---|
| Sinovation Laser Ablation System treatment | Experimental | Sinovation Laser Ablation System treatment Receives: Device: Sinovation Laser Ablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
MgLiTT ablation rate
Measurement of postsurgical MRI
Measured: Within 3 days after operation
Secondary outcomes (11)
Seizure free rate
Follow-up
Measured: 90±7 days after operation
Seizure reduction rate
Follow up
Measured: 90±7 days after operation
Operation time
Medical recording
Measured: Within 1 day after operation
Postsurgical hospitalization
Medical recording
Measured: Within 1 day after discharged from hospital
Mini-Mental State Examination (MMSE) score
Range from 0 to 30; Lower score indicates worse cognitive impairment
Measured: Before and 90±7 days after operation
Quality of life in epilepsy-31 inventory (QOLIE-31) score
For adult; Range from 0 to 100; Higher score indicates better quality of life
Measured: Before and 90±7 days after operation
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
Measured: Before and 90±7 days after operation
Vital signs-body temperature
From medical recording; Centigrade
Measured: Before and 2±1 days after operation
Vital signs-pulse
From medical recording; Times/minute
Measured: Before and 2±1 days after operation
Vital signs-respiratory rate
From medical recording; Times/minute
Measured: Before and 2±1 days after operation
Vital signs-blood pressure
From medical recording; Systolic pressure/diastolic pressure (mmHg)
Measured: Before and 2±1 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start8 Aug 2020
- Primary completion8 May 2021 (estimated)
- Study completion8 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Xuanwu Hospital, Beijing, Peking Union Medical College Hospital, Chinese PLA General Hospital, Peking University International Hospital
- Responsible party
- Sponsor
- Investigators
- Kai Zhang, Dr., Study director, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04569071
- Sponsor's protocol ID
- HK593202002
- Status last verified
- Sep 2020
- First submitted
- 10 Sep 2020
- Last updated
- 29 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We may only share clinical information (rather privacy information) in academic or other reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Clinical Trial to Evaluate the Efficacy and Safety of MRI-guided Laser Interstitial Thermal Therapy for Medical Refractory Epilepsy
- ClinicalTrials.gov ID
- NCT04569071
- Acronym / sponsor ID
- HK593202002
- Conditions
- Epilepsy
- Keywords
- Stereotactic surgery, Thermal ablation, Medical refractory epilepsy, Epilepsy surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Xuanwu Hospital, Beijing, Peking Union Medical College Hospital, Chinese PLA General Hospital, Peking University International Hospital
- Study start
- 8 Aug 2020 (actual)
- Primary completion
- 8 May 2021 (estimated)
- Study completion
- 8 Feb 2022 (estimated)
- First posted
- 29 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sinovation Laser Ablation System treatment | Experimental | Device: Sinovation Laser Ablation SystemSinovation Laser Ablation System treatment |
Who may qualify
- Ages
- 6 months to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sinovation Laser Ablation SystemIn the present single arm study. All eligible subjects will undergo MgLiTT with the Sinovation Laser Ablation System. | Device | Sinovation Laser Ablation System treatment |
Primary outcome
MgLiTT ablation rate
Time frame: Within 3 days after operation
Measurement of postsurgical MRI
11 secondary outcomes
Seizure free rate
Time frame: 90±7 days after operation
Seizure reduction rate
Time frame: 90±7 days after operation
Operation time
Time frame: Within 1 day after operation
Postsurgical hospitalization
Time frame: Within 1 day after discharged from hospital
Mini-Mental State Examination (MMSE) score
Time frame: Before and 90±7 days after operation
Quality of life in epilepsy-31 inventory (QOLIE-31) score
Time frame: Before and 90±7 days after operation
Quality of life in epilepsy for Adolescents (QOLIE-AD-48) score
Time frame: Before and 90±7 days after operation
Vital signs-body temperature
Time frame: Before and 2±1 days after operation
Vital signs-pulse
Time frame: Before and 2±1 days after operation
Vital signs-respiratory rate
Time frame: Before and 2±1 days after operation
Vital signs-blood pressure
Time frame: Before and 2±1 days after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
- Individual participant dataSharing planned: Yes. We may only share clinical information (rather privacy information) in academic or other reasonable request.
Related trials for Epilepsy
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Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
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Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kai Zhang, Dr. study director
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sinovation Laser Ablation System in people with Epilepsy, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kai Zhang, Dr. (+86 13501196619, zhangkai62035@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MgLiTT ablation rate (time frame: Within 3 days after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2020.