Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System

Movement Disorders Clinical Trial

— LAANTERN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02392078
• Other study ID #: LAANTERN
• Status: Completed
• Start date: October 2015
• Est. completion date: September 30, 2023

Study information

• Verified date: October 2023
• Source: Monteris Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 1,000 patients and up to 50 sites.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1057
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Epileptic/Seizure Foci
• Metastatic Brain Tumor
• Movement Disorders
• Primary Brain Tumor
• Seizures

Intervention

Device:
• NeuroBlate System

Locations

Country	Name	City	State
Canada	University of British Columbia	Vancouver	British Columbia
United States	Northwestern University	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Duke University Medical Center	Durham	North Carolina
United States	MD Anderson	Houston	Texas
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	University of California, San Diego	La Jolla	California
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Norton Cancer Institute	Louisville	Kentucky
United States	University of Louisville	Louisville	Kentucky
United States	University of Minnesota	Minneapolis	Minnesota
United States	Saint Thomas West Hospital and Research Institute	Nashville	Tennessee
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	New York University Langone Medical Center	New York	New York
United States	Children's Hospital of Orange County	Orange	California
United States	Advent Health Orlando	Orlando	Florida
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Barrow Neurological Institute at Dignity Health St. Joseph's Hospital & Medical Center	Phoenix	Arizona
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Washington University	Saint Louis	Missouri
United States	United Children's Hospital St. Paul	Saint Paul	Minnesota
United States	Johns Hopkins All Children's Hospital	Saint Petersburg	Florida
United States	SUNY Upstate Medical University	Syracuse	New York
United States	The Cleveland Clinic Florida	Weston	Florida
United States	Wake Forest	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Monteris Medical

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety (Reportable adverse events)	Safety profile described by the NBS and surgical-related AEs	up to 12 months
Primary	Reason for NeuroBlate	To identify the primary reason the NeuroBlate system was chosen for subject	Index procedure
Primary	Number of patients demonstrating local control, overall survival, and seizure freedom (ENGEL and ILAE classifications)	Collected for all subjects by disease etiology.; Local control as measured by time to local tumor recurrence.; Overall survival assessed by Kaplan-Meier method.; 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, Class II, Class III, Class IV) categorized by severity. The ILAE outcome scale contains six classes (Class 1, 2, 3, 4, 5, 6) categorized by severity.	up to 12 months or last follow-up
Primary	Change in Quality of Life	Assessed by the following questionnaires: KPS (subjects with CNS malignancy): Scale ranged 0-100 measuring the ability of patients with cancer to perform ordinary daily activities; FACT-Br (subjects with CNS malignancy): Measures general quality of life reflecting symptoms associated with brain malignancies across 5 scales (physical well-being social/family well-being, emotional well-being, functional well-being, and other); EQ-5D (all subjects): A generic measure of health consisting of the descriptive system and the visual analogue scale (VAS). The descriptive system assesses subject mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The VAS reports the subject's self-rated health; QOLIE-31 (subjects with epilepsy): Contains 7 scales assessing emotional well-being, social functioning, energy/fatigue, cognitive functioning, seizure worry, medication effects, and overall quality of life for adults	up to 12 months or last follow-up