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

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ClinicalTrials.gov Identifier: NCT02392078
Recruitment Status : Recruiting
First Posted : March 18, 2015
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Monteris Medical

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 1300 procedures conducted at approximately 56 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. Currently, the study has 162 subjects enrolled from 14 active sites

Condition or disease Intervention/treatment
Metastatic Brain Tumor Primary Brain Tumor Device: NeuroBlate System

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System (LAANTERN) Prospective Registry
Study Start Date : October 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : September 2020



Primary Outcome Measures :
  1. Procedural Success [ Time Frame: up to 12 months ]
  2. Local control Failure Rate [ Time Frame: up to 12 months ]
  3. Change in Quality of Life [ Time Frame: up to 12 months ]
    Assessed by KPS (CNS malignancy patients; through 24 months), EQ5D (all patients; through 12 months), FACT-Br (CNS malignancy patients; through 12 months), and Qolie-31 (patients with seizure foci; through 12 months).


Secondary Outcome Measures :
  1. Safety (Reportable adverse events) [ Time Frame: up to 12 months ]


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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
Patients who preferred management for soft tissue through interstitial irradiation or thermal therapy by the NeuroBlate® System, in the opinion of the treating physician
Criteria

Inclusion Criteria:

  1. Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
  2. Patient who is to undergo thermal therapy by the NeuroBlate® System for treatment of their neurological disorder

Exclusion Criteria:

  1. Patient who is, or is expected to be inaccessible for follow-up
  2. Patient meets any exclusion criteria required by local law (e.g. age)
  3. 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

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
Contact: Nissa Mollema 763-253-4710 nmollema@monteris.com
Contact: Aurelius Butler (763) 762-2715 ext 2715 abutler@monteris.com

Locations
United States, Arizona
Barrow Neurological Institute at Dignity Health St. Joseph's Hospital & Medical Center Recruiting
Phoenix, Arizona, United States, 85013
Contact: Odilette Trevizo, RN, CNRN    602-406-1463    Odilette.Trevizo@DignityHealth.org   
Principal Investigator: Kris Smith, MD         
United States, California
University of California, San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Lara Rose    858-822-6575    ljrose@ucsd.edu   
Principal Investigator: David Piccioni, MD         
United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06510
Contact: Judith Hess    203-737-6259    judith.hess@yale.edu   
Principal Investigator: Veronica Chiang, MD         
United States, Florida
Florida Hospital Recruiting
Orlando, Florida, United States, 32804
Contact: Gabriella Anderson    407-303-3214    Gabriella.Anderson@flhosp.org   
Principal Investigator: Melvin Field, MD         
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Lindsay Richardson    913-574-0412    lrichardson5@kumc.edu   
Contact: Catherine Lauridsen    913-588-4573    clauridsen2@kumc.edu   
Principal Investigator: Patrick Landazuri, MD         
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40208
Contact: Anna Williford    502-852-7402    aowill01@louisville.edu   
Principal Investigator: Joseph Neimat, MD         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Nonyelum Harcourt    612-624-8117    Harco002@umn.edu   
Principal Investigator: Clark Chen, MD         
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Jeanine Portell    314-362-2940    jportell@wustl.edu   
Principal Investigator: Albert Kim, MD         
United States, New York
Ichan School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Ryan Adams       Ryan.Adams@mountsinai.org   
Principal Investigator: Constantino Hadjipanayis, MD         
Weill Cornell Medicine Recruiting
New York, New York, United States, 10065
Contact: Alyson Hignight    212-746-1788    alh2031@med.cornell.edu   
Principal Investigator: Rohan Ramakrishna, MD         
SUNY Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Contact: Sean Huckins    315-464-8477    huckinss@upstate.edu   
Principal Investigator: Zulma Tovar-Spinoza, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Alexia Bwensa    919-681-5484    alexia.bwensa@duke.edu   
Principal Investigator: Peter Fecci, MD         
Wake Forest Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Wendy Jenkins    336-716-3842    wejenkin@wakehealth.edu   
Principal Investigator: Stephen Tatter, MD         
United States, Ohio
University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Karen Devine    213-368-0076    karen.devine@uhhospitals.org   
Principal Investigator: Andrew Sloan, MD         
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Teresa Allison    216-444-6459    ALLISOT@ccf.org   
Principal Investigator: Alireza Mohammadi, MD         
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Jaime Dougherty    215-955-7962    Jaime.Dougherty@jefferson.edu   
Principal Investigator: Kevin Judy, MD         
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Patricia Porter    412-648-8983    porterpm2@upmc.edu   
Principal Investigator: Mark Richardson, MD         
United States, Texas
MD Anderson Recruiting
Houston, Texas, United States, 77030
Contact: Carmen Jacobs    713-745-3246    cjacobs@mdanderson.org   
Principal Investigator: Ganesh Rao, MD         
Canada, British Columbia
University of British Columbia Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Ru Chen Guo    604-875-4111 ext 61505    rchen.guo@ubc.ca   
Principal Investigator: Brian Toyota, MD         
Sponsors and Collaborators
Monteris Medical
Investigators
Principal Investigator: Eric Leuthardt, MD Washington University School of Medicine

Responsible Party: Monteris Medical
ClinicalTrials.gov Identifier: NCT02392078     History of Changes
Other Study ID Numbers: LAANTERN
First Posted: March 18, 2015    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018

Keywords provided by Monteris Medical:
Procedural Success
Progression
Quality of Life

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases