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

Monteris Medical

Status: Completed

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

Treatments: Device: NeuroBlate System

Study type: Observational

Funder types: Industry

Identifiers

NCT02392078

LAANTERN

Details and patient eligibility

About

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.

Enrollment: 1,153 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design