Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System

Completed

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

Registration Number: NCT02392078

Lead Sponsor: Monteris Medical

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1153

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety (Reportable Adverse Events)	up to 5 years or last follow up	Safety profile described by the NBS and surgical-related AEs
Reason for NeuroBlate	Index procedure	To identify the primary reason the NeuroBlate system was chosen for subject
Number of Patients Demonstrating Seizure Freedom (ENGEL and ILAE Classifications)	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.
Change in Quality of Life	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
Number of Patients Demonstrating Local Control and Overall Survival	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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (26): The Cleveland Clinic Florida
🇺🇸
Weston, Florida, United States
Washington University
🇺🇸
Saint Louis, Missouri, United States
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
Advent Health Orlando
🇺🇸
Orlando, Florida, United States
Johns Hopkins All Children's Hospital
🇺🇸
Saint Petersburg, Florida, United States
Northwestern University
🇺🇸
Chicago, Illinois, United States
University of Kansas Medical Center
🇺🇸
Kansas City, Kansas, United States
University of Louisville
🇺🇸
Louisville, Kentucky, United States
Norton Cancer Institute
🇺🇸
Louisville, Kentucky, United States
University of Minnesota
🇺🇸
Minneapolis, Minnesota, United States
United Children's Hospital St. Paul
🇺🇸
Saint Paul, Minnesota, United States
New York University Langone Medical Center
🇺🇸
New York, New York, United States
Icahn School of Medicine at Mount Sinai
🇺🇸
New York, New York, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
Wake Forest
🇺🇸
Winston-Salem, North Carolina, United States
University Hospitals Cleveland Medical Center
🇺🇸
Cleveland, Ohio, United States
Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
Geisinger Medical Center
🇺🇸
Danville, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸
Pittsburgh, Pennsylvania, United States
Saint Thomas West Hospital and Research Institute
🇺🇸
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
🇺🇸
Dallas, Texas, United States
MD Anderson
🇺🇸
Houston, Texas, United States