Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System (LAANTERN) Prospective Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,153
- 试验地点
- 26
- 主要终点
- Safety (Reportable Adverse Events)
研究概览
简要总结
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 3,000 patients and up to 50 sites.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Safety (Reportable Adverse Events)
时间窗: up to 5 years or last follow up
Safety profile described by the NBS and surgical-related AEs
Reason for NeuroBlate
时间窗: Index procedure
To identify the primary reason the NeuroBlate system was chosen for subject
Number of Patients Demonstrating Seizure Freedom (ENGEL and ILAE Classifications)
时间窗: up to 5 years or last follow up
Collected for all subjects by disease etiology. 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 (best), Class II, Class III, Class IV (worst)) categorized by severity. The ILAE outcome scale contains six classes (Class 1 (best), 2, 3, 4, 5, 6 (worst)) categorized by severity.
Number of Patients Demonstrating Local Control and Overall Survival
时间窗: up to 5 years or last follow up
Collected for all subjects by disease etiology. Local control as measured by time to local tumor recurrence. Overall survival assessed by Kaplan-Meier method.
Change in Quality of Life
时间窗: up to 5 years or last follow-up
Assessed with following questionnaires: 1. KPS (malignancy subjects only) Scale range 0-100 measuring the ability of patients with cancer to perform ordinary daily activities. Score 0 is dead, 100 is no disease symptoms 2. FACT-Br (malignancy subjects only) Measure general quality of life across 5 scales- physical well-being, social/family well-being, emotional well-being, functional well-being \& other. Higher score, better quality of life. Range 0-200 3. EQ-5D (tumor/epilepsy subjects only) Measure of health consisting of the descriptive system \& the visual analogue scale (VAS). The system assesses subject mobility, self-care, usual activities, pain/discomfort \& anxiety/depression. Higher score, better quality of life. Range 0-100 4. QOLIE-31 (epilepsy subjects only) 7 scales assessing emotional well-being, social functioning, energy/fatigue, cognitive functioning, seizure worry, medication effects, \& overall quality of life. Higher score, better quality of life. Range 0-100
次要结局
未报告次要终点