Clinical trial NCT02392078: Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System
Official title: Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System (LAANTERN) Prospective Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Brain Tumor
Primary Brain Tumor
Epileptic/Seizure Foci
Movement Disorders
Keywords: Procedural Success
Progression
Quality of Life
Seizure Freedom
Progression Free Survival
Overall Survival
Lead sponsor: Monteris Medical
Sponsor class: INDUSTRY
First posted: 2015-03-18
Enrollment: 1153
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who present with a brain lesion, epileptic/seizure foci, or movement disorder who have been deemed appropriate candidates, in the opinion of the treating physician, for laser ablation using the NeuroBlate® System.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety (Reportable Adverse Events)
timeFrame: up to 5 years or last follow up
measure: Reason for NeuroBlate
timeFrame: Index procedure
measure: Number of Patients Demonstrating Seizure Freedom (ENGEL and ILAE Classifications)
timeFrame: up to 5 years or last follow up
measure: Change in Quality of Life
timeFrame: up to 5 years or last follow-up
measure: Number of Patients Demonstrating Local Control and Overall Survival
timeFrame: up to 5 years or last follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute at Dignity Health St. Joseph's Hospital & Medical Center
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Orlando
country: United States
facility: Advent Health Orlando
state: Florida
city: Saint Petersburg
country: United States
facility: Johns Hopkins All Children's Hospital
state: Florida
city: Weston
country: United States
facility: The Cleveland Clinic Florida
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Saint Paul
country: United States
facility: United Children's Hospital St. Paul
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: New York
country: United States
facility: New York University Langone Medical Center
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Saint Thomas West Hospital and Research Institute
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: MD Anderson
state: Texas
Study officials:
affiliation: Washington University School of Medicine
name: Eric Leuthardt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Landazuri P, Shih J, Leuthardt E, Ben-Haim S, Neimat J, Tovar-Spinoza Z, Chiang V, Spencer D, Sun D, Fecci P, Baumgartner J. A prospective multicenter study of laser ablation for drug resistant epilepsy - One year outcomes. Epilepsy Res. 2020 Nov;167:106473. doi: 10.1016/j.eplepsyres.2020.106473. Epub 2020 Sep 22.
citation: Kim AH, Tatter S, Rao G, Prabhu S, Chen C, Fecci P, Chiang V, Smith K, Williams BJ, Mohammadi AM, Judy K, Sloan A, Tovar-Spinoza Z, Baumgartner J, Hadjipanayis C, Leuthardt EC. Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System (LAANTERN): 12-Month Outcomes and Quality of Life After Brain Tumor Ablation. Neurosurgery. 2020 Sep 1;87(3):E338-E346. doi: 10.1093/neuros/nyaa071.
citation: Rennert RC, Khan U, Bartek J, Tatter SB, Field M, Toyota B, Fecci PE, Judy K, Mohammadi AM, Landazuri P, Sloan AE, Kim AH, Leuthardt EC, Chen CC. Laser Ablation of Abnormal Neurological Tissue Using Robotic Neuroblate System (LAANTERN): Procedural Safety and Hospitalization. Neurosurgery. 2020 Apr 1;86(4):538-547. doi: 10.1093/neuros/nyz141.