Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System

NCT02392078 | Completed Results

• 1 other identifier: LAANTERN
• Study Type: observational
• Target: 1,153
• Locations: 1 country
• Sites: 26

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.

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

Outcome Measures

Primary Outcomes (5)

• Safety (Reportable Adverse Events)

  Safety profile described by the NBS and surgical-related AEs

  up to 5 years or last follow up

• Reason for NeuroBlate

  To identify the primary reason the NeuroBlate system was chosen for subject

  Index procedure

• Number of Patients Demonstrating Seizure Freedom (ENGEL and ILAE Classifications)

  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.

  up to 5 years or last follow up

• Change in Quality of Life

  Assessed with following questionnaires: 1. 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 2. 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 3. 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 4. 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

  up to 5 years or last follow-up

• Number of Patients Demonstrating Local Control and Overall Survival

  Collected for all subjects by disease etiology. Local control as measured by time to local tumor recurrence. Overall survival assessed by Kaplan-Meier method.

  up to 5 years or last follow up

Interventions

NeuroBlate System DEVICE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Monteris Medical: lead

Study Sites (26)

Barrow Neurological Institute at Dignity Health St. Joseph's Hospital & Medical Center

Phoenix, Arizona, 85013, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

University of California, San Diego

La Jolla, California, 92093, United States

Location

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

Advent Health Orlando

Orlando, Florida, 32804, United States

Location

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

The Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Louisville

Louisville, Kentucky, 40208, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40241, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

United Children's Hospital St. Paul

Saint Paul, Minnesota, 55102, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

New York University Langone Medical Center

New York, New York, 10016, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Wake Forest

Winston-Salem, North Carolina, 27157, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Saint Thomas West Hospital and Research Institute

Nashville, Tennessee, 37205, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MD Anderson

Houston, Texas, 77030, United States

Location

Related Publications (3)

• 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.

  PMID: 33045664 DERIVED

• 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.

  PMID: 32315434 DERIVED

• 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.

  PMID: 31076762 DERIVED

MeSH Terms

Conditions

Brain Neoplasms; Epilepsy; Movement Disorders; Disease Progression

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Christa Seligman
• Organization: Monteris Medical

cseligman@monteris.com

(952) 463-7747

Study Officials

• Eric Leuthardt, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2015
• First Posted: March 18, 2015
• Study Start: October 1, 2015
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: April 24, 2025
• Results First Posted: April 24, 2025

Record last verified: 2025-04

Locations

US (26)