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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 : March 4, 2019
Sponsor:
Information provided by (Responsible Party):
Monteris Medical

Tracking Information
First Submitted Date March 12, 2015
First Posted Date March 18, 2015
Last Update Posted Date March 4, 2019
Study Start Date October 2015
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 2, 2018)
  • Procedural Success [ Time Frame: up to 12 months ]
  • Local control Failure Rate [ Time Frame: up to 12 months ]
  • 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).
Original Primary Outcome Measures
 (submitted: March 17, 2015)
  • 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 ]
Change History Complete list of historical versions of study NCT02392078 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 17, 2015)
Safety (Reportable adverse events) [ Time Frame: up to 12 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System
Official Title Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System (LAANTERN) Prospective Registry
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 2000 procedures conducted at over 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Metastatic Brain Tumor
  • Primary Brain Tumor
Intervention Device: NeuroBlate System
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 17, 2015)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Nissa Mollema 763-253-4710 nmollema@monteris.com
Contact: Aurelius Butler (763) 762-2715 ext 2715 abutler@monteris.com
Listed Location Countries Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02392078
Other Study ID Numbers LAANTERN
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Monteris Medical
Study Sponsor Monteris Medical
Collaborators Not Provided
Investigators
Principal Investigator: Eric Leuthardt, MD Washington University School of Medicine
PRS Account Monteris Medical
Verification Date March 2019