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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by Monteris Medical
Sponsor:
Information provided by (Responsible Party):
Monteris Medical
ClinicalTrials.gov Identifier:
NCT02392078
First received: March 12, 2015
Last updated: October 13, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention
Metastatic Brain Tumor
Primary Brain Tumor
Device: NeuroBlate System

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System (LAANTERN) Prospective Registry

Further study details as provided by Monteris Medical:

Primary Outcome Measures:
  • Procedural Success [ Time Frame: up to 12 months ]
  • Local control Failure Rate [ Time Frame: up to 12 months ]
  • Quality of Life [ Time Frame: up to 12 months ]

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

Estimated Enrollment: 1000
Study Start Date: October 2015
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02392078

Contacts
Contact: Audrey Singh 763-253-4717 asingh@monteris.com

Locations
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: Clark Chen, md         
United States, Connecticut
Yale University School of Medicine Not yet 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: Karin Donaldson    407-303-2944    karin.donaldson@flhosp.org   
Principal Investigator: Melvin Field, MD         
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Cathy T Lauridsen    913-588-4573    clauridsen2@kumc.edu   
United States, Missouri
Washington University Recruiting
St. Louis, Missouri, United States, 63110
Contact: Jeanine Wade    314-362-2940    jeanine.wade@wustl.edu   
Principal Investigator: Eric Leuthardt, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Kristy Averette    919-684-0380    kristy.l.johnson@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: Jennifer Fahrion    216-983-5169    jennifer.fahrion@uhhospitals.org   
Principal Investigator: Andrew Sloan, MD         
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Dee Walick    216-445-8797    walickd@ccf.org   
Principal Investigator: Alireza Mohammadi, MD         
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Kara Pigott    215-503-9110    kara.pigott@jefferson.edu   
Principal Investigator: Kevin Judy, MD         
Canada, British Columbia
University of British Columbia Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Camille Hunt    604-875-4111 ext 62560    camille.hunt@ubc.ca   
Principal Investigator: Brian Toyota, MD         
Sponsors and Collaborators
Monteris Medical
  More Information

Responsible Party: Monteris Medical
ClinicalTrials.gov Identifier: NCT02392078     History of Changes
Other Study ID Numbers: LAANTERN 
Study First Received: March 12, 2015
Last Updated: October 13, 2016

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

ClinicalTrials.gov processed this record on February 24, 2017