Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System

Study Overview
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Brief Summary
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The NeuroBlate® System (NBS) is a minimally invasive robotic laser thermotherapy tool that is being manufactured by Monteris Medical. Since it received FDA clearance in May 2009, the NBS has been used in over 2600 procedures conducted at over 70 leading institutions across United States. This is a prospective, multi-center registry that will include data collection up to 5 years to evaluate safety, QoL, and procedural outcomes including local control failure rate, progression free survival, overall survival, and seizure freedom in up to 1,000 patients and up to 50 sites.

Official Title
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Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System (LAANTERN) Prospective Registry

Conditions
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Metastatic Brain Tumor, Primary Brain Tumor, Epileptic/Seizure Foci, Movement Disorders

Intervention / Treatment
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* Device: NeuroBlate System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject or legally authorized representative provides written authorization and/or consent Subject who is to undergo thermal therapy by the NeuroBlate® System for treatment of their neurological disorder Exclusion Criteria: Subject who is, or is expected to be inaccessible for follow-up Other concurrent medical or other condition (chronic or acute in nature) that in the opinion of the investigator, may prevent participation or otherwise render subject ineligibility for the study
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: NeuroBlate System|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (Reportable adverse events) | Safety profile described by the NBS and surgical-related AEs | up to 12 months | 
| Reason for NeuroBlate | To identify the primary reason the NeuroBlate system was chosen for subject | Index procedure | 
| Number of patients demonstrating local control, overall survival, and seizure freedom (ENGEL and ILAE classifications) | Collected for all subjects by disease etiology. Local control as measured by time to local tumor recurrence. Overall survival assessed by Kaplan-Meier method. Seizure freedom assessed for all subjects with epilepsy at time of last follow-up. The ENGEL surgical outcome scale is composed of four classes of epilepsy (Class I, Class II, Class III, Class IV) categorized by severity. The ILAE outcome scale contains six classes (Class 1, 2, 3, 4, 5, 6) categorized by severity. | up to 12 months or last follow-up | 
| Change in Quality of Life | Assessed by the following questionnaires: KPS (subjects with CNS malignancy): Scale ranged 0-100 measuring the ability of patients with cancer to perform ordinary daily activities FACT-Br (subjects with CNS malignancy): Measures general quality of life reflecting symptoms associated with brain malignancies across 5 scales (physical well-being social/family well-being, emotional well-being, functional well-being, and other) EQ-5D (all subjects): A generic measure of health consisting of the descriptive system and the visual analogue scale (VAS). The descriptive system assesses subject mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The VAS reports the subject's self-rated health QOLIE-31 (subjects with epilepsy): Contains 7 scales assessing emotional well-being, social functioning, energy/fatigue, cognitive functioning, seizure worry, medication effects, and overall quality of life for adults | up to 12 months or last follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Procedural Success, Progression, Quality of Life, Seizure Freedom, Progression Free Survival, Overall Survival