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

December 13, 2023 updated by: Monteris Medical

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1057

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • University of British Columbia
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Barrow Neurological Institute at Dignity Health St. Joseph's Hospital & Medical Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • California
      • La Jolla, California, United States, 92093
        • University of California, San Diego
      • Orange, California, United States, 92868
        • Children's Hospital of Orange County
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University School Of Medicine
    • Florida
      • Orlando, Florida, United States, 32804
        • Advent Health Orlando
      • Saint Petersburg, Florida, United States, 33701
        • Johns Hopkins All Children's Hospital
      • Weston, Florida, United States, 33331
        • The Cleveland Clinic Florida
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Kentucky
      • Louisville, Kentucky, United States, 40241
        • Norton Cancer Institute
      • Louisville, Kentucky, United States, 40208
        • University of Louisville
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
      • Saint Paul, Minnesota, United States, 55102
        • United Children's Hospital St. Paul
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10016
        • New York University Langone Medical Center
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37205
        • Saint Thomas West Hospital and Research Institute
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • Houston, Texas, United States, 77030
        • MD Anderson

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety (Reportable adverse events)
Time Frame: up to 12 months
Safety profile described by the NBS and surgical-related AEs
up to 12 months
Reason for NeuroBlate
Time Frame: Index procedure
To identify the primary reason the NeuroBlate system was chosen for subject
Index procedure
Number of patients demonstrating local control, overall survival, and seizure freedom (ENGEL and ILAE classifications)
Time Frame: up to 12 months 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.

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
Change in Quality of Life
Time Frame: up to 12 months or last follow-up

Assessed by the following questionnaires:

  1. KPS (subjects with CNS malignancy): Scale ranged 0-100 measuring the ability of patients with cancer to perform ordinary daily activities
  2. 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)
  3. 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
  4. 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Monteris Medical

Investigators

  • Principal Investigator: Eric Leuthardt, MD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

March 12, 2015

First Submitted That Met QC Criteria

March 17, 2015

First Posted (Estimated)

March 18, 2015

Study Record Updates

Last Update Posted (Actual)

December 14, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAANTERN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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