Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06341075
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-02
First Post:
2024-03-21
Brief Title:
Real-World Study of Magnetic Resonance-guided Laser Interstitial Thermal Therapy for Drug-resistant Epilepsy
Sponsor:
Beijing Tiantan Hospital
Organization:
Beijing Tiantan Hospital
Study Overview
Official Title:
Real-World Study of Magnetic Resonance-guided Laser Interstitial Thermal Therapy for Patients With Drug-resistant Epilepsy
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of the real-world study is to evaluate the long-term seizure control outcomes postoperative complications long term impact on cognitive memory function outcomes quality-of-life measures and healthcare resource utilization of magnetic resonance-guided laser interstitial thermal therapy MRgLITT on patients with drug-resistant epilepsy DRE
Detailed Description:
Epilepsy a complex neurological disorder characterized by recurrent seizures affects millions of individuals worldwide challenging both patients and healthcare providers The main indication for the epilepsy surgery is the drug resistance as per the consensus from the Task Force of the International League Against Epilepsy ILAE Traditional open surgery is an established treatment for drug-resistant epilepsy DRE but has limitations such as invasiveness and long recovery times With the significant advancements of technology the minimally invasive therapeutic approaches have emerged among which Magnetic Resonance-guided Laser Interstitial Thermal Therapy MRgLITT stands out as a promising intervention It provides targeted ablation of epileptogenic tissue while preserving healthy brain regions Understanding MRgLITTs comprehensive value for DRE is of increasing interest
This real-world study aims to comprehensively evaluate the clinical outcomes safety profiles and cost-effectiveness of MRgLITT in patients with DRE The results of this clinical trial protocol are expected to serve as a comprehensive guide for researchers clinicians and stakeholders interested in the treatment of DRE using MRgLITT We believe this study can influence future treatment strategies leading to improved outcomes and enhanced quality of life for individuals with epilepsy
This real-world study aims to comprehensively evaluate the clinical outcomes safety profiles and cost-effectiveness of MRgLITT in patients with DRE The results of this clinical trial protocol are expected to serve as a comprehensive guide for researchers clinicians and stakeholders interested in the treatment of DRE using MRgLITT We believe this study can influence future treatment strategies leading to improved outcomes and enhanced quality of life for individuals with epilepsy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None