Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System

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.

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Key information

Conditions

Metastatic Brain Tumor Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Disease Attributes Disease Progression Epilepsy Epileptic/Seizure Foci Movement Disorders Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Primary Brain Tumor

Sex eligibility

All sexes

Study type

Observational

Primary location

Barrow Neurological Institute at Dignity Health St. Joseph's Hospital & Medical Center, Phoenix, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NeuroBlate System

Device

Primary outcomes

Safety (Reportable Adverse Events)

Time frame: up to 5 years or last follow up

Safety profile described by the NBS and surgical-related AEs
Reason for NeuroBlate

Time frame: Index procedure

To identify the primary reason the NeuroBlate system was chosen for subject
Number of Patients Demonstrating Seizure Freedom (ENGEL and ILAE Classifications)

Time frame: 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

Time frame: up to 5 years or last follow-up
Assessed with following questionnaires:
- 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
- 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
- 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
- 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Monteris Medical

Industry

Registry information

Official study title

Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System (LAANTERN) Prospective Registry

Acronym: LAANTERN

Important dates

Study start: 2015
Primary completion: 2023
Study completion: 2023
First posted: Mar 18, 2015
Registry last updated: Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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