Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System

N/ACompletedNCT02392078

Monteris Medical1,153 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,153

Conditions

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

Interventions

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subject or legally authorized representative provides written authorization and/or consent 2. Subject who is to undergo thermal therapy by the NeuroBlate® System for treatment of their neurological disorder Exclusion Criteria: 1. Subject who is, or is expected to be inaccessible for follow-up 2. 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

Locations (26)

Barrow Neurological Institute at Dignity Health St. Joseph's Hospital & Medical Center

Phoenix, Arizona, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

University of California, San Diego

La Jolla, California, United States

Children's Hospital of Orange County

Orange, California, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Safety (Reportable Adverse Events)

Safety profile described by the NBS and surgical-related AEs

Time frame: up to 5 years or last follow up

Reason for NeuroBlate

To identify the primary reason the NeuroBlate system was chosen for subject

Time frame: Index procedure

Number of Patients Demonstrating Seizure Freedom (ENGEL and ILAE Classifications)

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.

Time frame: up to 5 years or last follow up

Change in Quality of Life

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

Time frame: up to 5 years or last follow-up

Number of Patients Demonstrating Local Control and Overall Survival

Collected for all subjects by disease etiology. Local control as measured by time to local tumor recurrence. Overall survival assessed by Kaplan-Meier method.

Time frame: up to 5 years or last follow up