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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02392078
Recruitment Status : Recruiting
First Posted : March 18, 2015
Last Update Posted : March 16, 2023
Sponsor:
Information provided by (Responsible Party):
Monteris Medical

Study Description
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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 1,000 patients and up to 50 sites.

Condition or disease Intervention/treatment
Metastatic Brain Tumor Primary Brain Tumor Epileptic/Seizure Foci Movement Disorders Device: NeuroBlate System

Study Design
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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System (LAANTERN) Prospective Registry
Actual Study Start Date : October 2015
Estimated Primary Completion Date : December 2030
Estimated Study Completion Date : December 2035
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Safety (Reportable adverse events) [ Time Frame: up to 12 months ]
    Safety profile described by the NBS and surgical-related AEs

  2. Reason for NeuroBlate [ Time Frame: Index procedure ]
    To identify the primary reason the NeuroBlate system was chosen for subject

  3. 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.


  4. 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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02392078


Contacts
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Contact: Laura Menck lmenck@monteris.com

Locations
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Sponsors and Collaborators
Monteris Medical
Investigators
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Principal Investigator: Eric Leuthardt, MD Washington University School of Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Monteris Medical
ClinicalTrials.gov Identifier: NCT02392078    
Other Study ID Numbers: LAANTERN
First Posted: March 18, 2015    Key Record Dates
Last Update Posted: March 16, 2023
Last Verified: September 2022
Keywords provided by Monteris Medical:
Procedural Success
Progression
Quality of Life
 Seizure Freedom
Progression Free Survival
Overall Survival
Additional relevant MeSH terms:
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Brain Neoplasms
Seizures
Movement Disorders
Neoplasms
Neurologic Manifestations
Nervous System Diseases
 Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases