The need for new technologies and devices in the field of neurosurgery is well established. In April 2013, FDA cleared NeuroBlate™ System, minimally invasive robotic laser thermotherapy tool. It employs a pulsed surgical laser to deliver targeted energy to abnormal brain tissue caused by tumors and lesions. This post-marketing, multi-center study will include patients with metastatic tumors who failed stereotactic radiosurgery and are already scheduled for NeuroBlate procedure. The study will collect clinical outcome, Quality of Life (QoL) and, where feasible, healthcare utilization data for publication.
Study Type
OBSERVATIONAL
Enrollment
44
Yale School of Medicine
New Haven, Connecticut, United States
Kansas University Medical Center
Kansas City, Kansas, United States
Washington University in St Louis
St Louis, Missouri, United States
Carolina Neurosurgery & Spine Associates
Charlotte, North Carolina, United States
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Percentage of Patients With Progression-Free Survival (PFS)
To describe local (CNS) progression-free survival rate in patients with failed radiosurgery for brain metastases treated with the NeuroBlate System. Sites were requested to submit imaging to a centralized core laboratory for analysis. A total of 27 patients had images submitted--27/42 (64%) of patients submitted follow-up images at 12-weeks and 16/42 (38%) patients submitted follow-up imaging at 26 weeks. Due to the low submission of follow-up images at 26-weeks, 12-weeks and last follow-up are reported.
Time frame: Images were collected at 12 and 26 weeks post index procedure.
Quality of Life (Change in The Functional Assessment of Cancer Therapy-Brain (FACT-Br) Score.
FACT-Br questionnaire sub-scores (Physical well-being, social/family well-being, emotional well-being, functional well-being, brain cancer subscale) are summed together, leading to a FACT-Br total score on a scale from 0-200; larger scores indicate better overall quality of life. This outcome measured the FACT-Br score change from Baseline at both 12 and 26 weeks post NeuroBlate procedure (values at 12 and 26 weeks, respectively, minus value at baseline). Version 4 of the Fact-BR scoring guidelines were used.
Time frame: baseline, 12 and 26 weeks post index procedure
Overall Survival
To describe/estimate the overall survival after the NeuroBlate Procedure.
Time frame: 12 and 26 weeks post index procedure
Percentage of Patients With Laser Ablation Related Adverse Events
To continue to monitor factors impacting the safe and efficacious use of NeuroBlate
Time frame: All adverse events reported through 26 weeks post index procedure
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