Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System

Completed

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

In brief

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.

Key facts

Study ID

NCT02392078

Run by

Monteris Medical

People needed

1153

Starts

2015-10-01

Expected to finish

2023-09-30

Last updated by the study team

2025-04-24

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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 — St. Petersburg, Florida, United States
• The Cleveland Clinic Florida — Weston, 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
• Washington University — St Louis, Missouri, 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

Full record on ClinicalTrials.gov

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