Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System (LAANTERN)
- Study HIC#:1507016142REG
- Last Updated:07/15/2021
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 April 2013, the NBS has been used in over 300 procedures conducted at approximately 20 leading institutions across United States. This is a prospective, multi-center registry that will include data collection up to 12 months to evaluate procedural success, local control failure rate, and QoL in up to 1,000 patients and up to 50 sites.
- Start Date01/23/2017
- End Date06/30/2020
Trial Purpose and Description
This is a multi-center registry that is designed to collect baseline, procedural and follow-up data on patients that are already scheduled to be treated or have been treated with the Neuroblate System NBS). The aim of this post-market study is to further understand performance and utilization of the NBS in current standard of care.
- Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
- Patient who is to undergo thermal therapy by the NeuroBlate® System for treatment of their neurological disorder
- Patient who is, or is expected to be inaccessible for follow-up
- Patient meets any exclusion criteria required by local law (e.g. age)
- Other concurrent medical or other condition (chronic or acute in nature) that in the opinion of the investigator may prevent participation or otherwise render patient ineligibility for the study