N/A
Completed N=1,153
Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System
Metastatic Brain Tumor · Brain Cancer · Epileptic/Seizure Foci · Movement Disorders
Source: ClinicalTrials.gov NCT02392078 ↗
Enrolled (actual)
1,153
Serious AEs
2.9%
Results posted
Apr 2025
Primary outcomePrimary: Safety (Reportable Adverse Events) — 1; 7; 2; 30 Participants
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 2600 procedures conducted at over 70 leading institutions across United States. This is a prospective, multi-center registry that will include data collection up to 5 years to evaluate safety, QoL, and procedural outcomes including local control failure rate, progression free survival, overall survival, and seizure freedom in up to 3,000 patients and up to 50 sites.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety (Reportable Adverse Events) |
1; 7; 2; 30; 3; 21 | — |
| PRIMARY Reason for NeuroBlate |
702; 186; 24; 31; 7; 139 | — |
| PRIMARY Number of Patients Demonstrating Seizure Freedom (ENGEL and ILAE Classifications) |
88; 34; 29; 21; 96; 58 | — |
| PRIMARY Change in Quality of Life |
90; 80; 149; 149; 80; 80 | — |
| PRIMARY Number of Patients Demonstrating Local Control and Overall Survival |
3.44; 3.26; 4.69; 4.27 | — |
Eligibility Criteria
Inclusion Criteria
- Subject or legally authorized representative provides written authorization and/or consent
- Subject who is to undergo thermal therapy by the NeuroBlate® System for treatment of their neurological disorder
Exclusion Criteria
- Subject who is, or is expected to be inaccessible for follow-up
- Other concurrent medical or other condition (chronic or acute in nature) that in the opinion of the investigator, may prevent participation or otherwise render subject ineligibility for the study
Data sourced from ClinicalTrials.gov (NCT02392078). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.