Clinical Trial of MgLiTT for Medical Refractory Epilepsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-08

Study Completion Date

2022-02-08

Brief Summary

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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.

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Detailed Description

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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

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Epilepsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sinovation Laser Ablation System treatment

Group Type EXPERIMENTAL

Sinovation Laser Ablation System

Intervention Type DEVICE

In the present single arm study. All eligible subjects will undergo MgLiTT with the Sinovation Laser Ablation System.

Interventions

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Sinovation Laser Ablation System

In the present single arm study. All eligible subjects will undergo MgLiTT with the Sinovation Laser Ablation System.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

6 Months

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No