Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System

Description

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.

Study Start Date

October 2015

Estimated Completion Date

September 2020

Interventions

  • Device: NeuroBlate System

Specialties

  • Surgery: Neurosurgery
  • Neurology: Neurologic Oncology,Neurosurgery
  • Oncology: Neurologic Oncology

MeSH Terms

  • Brain Neoplasms
  • Central Nervous System Diseases

Study ID

Monteris Medical -- LAANTERN

Status

Recruiting

Trial ID

NCT02392078

Study Type

Observational

Trial Phase

N/A

Enrollment Quota

1000

Sponsor

Monteris Medical

Inclusion Criteria

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

Exclusion Criteria

  • Patients unable or unwilling to sign ICF
  • Females who are pregnant, breast feeding, or plan to become pregnant in the 6 months following NeuroBlate┬« System therapy
  • Serious infection, immunosuppression or concurrent medical condition (chronic or acute in nature) that may prevent safe participation or ability to meet follow-up requirements.
  • Patients whose physical dimensions cannot be accommodated in the MRI scanner or patients with contraindications to MRI imaging such as pacemakers, non-compatible aneurysm clips, shrapnel and other internal ferromagnetic objects.

Gender

Both

Ages

N/A

Accepts Healthy Volunteers

No

Study Locations and Contact Information (8)

Study Location Distance Name Phone Email
Yale University School of Medicine - New Haven, Connecticut 18.2 miles Judith Hess 203-752-7430 judith.hess@yale.edu
Thomas Jefferson University - Philadelphia, Pennsylvania 133.3 miles Allyson Blackwell 215-503-4852 allyson.blackwell@jefferson.edu
University Hospitals of Cleveland - Cleveland, Ohio 434.6 miles Gina Cascone None gina.cascone@uhhospitals.org
Cleveland Clinic Foundation - Cleveland, Ohio 435.4 miles Theresa Naska 216-444-8923 naskat@ccf.org
Wake Forest - Winston-Salem, North Carolina 523.1 miles Wendy Jenkins 336-716-3842 wejenkin@wakehealth.edu
Washington University - St. Louis, Missouri 919.8 miles M Eileen Jacobs 314-362-4110 jacobse@mir.wustl.edu
Florida Hospital - Orlando, Florida 989.4 miles Karin Donaldson 407-303-2944 karin.donaldson@flhosp.org
University of California San Diego - La Jolla, California 2,471.8 miles Bradley Brown 858-822-5377 bdbrown@ucsd.edu

ClinicalTrialsLocator.com provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from ClinicalTrials.gov. This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.