Primary Brain Tumor
Conditions
Keywords
Progression, Quality of Life
Brief summary
The NeuroBlate® System (NBS), is a 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. Since receiving FDA clearance in April 2013, the NBS has been used in nearly 300 procedures conducted at approximately 20 leading institutions across the United States. This post-market, multi-center retrospective study is designed to collect long-term follow-up data on patients who were treated previously with NBS.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
* Patient was previously treated with NBS * Patient is willing and able to provide informed consent and authorization for release of personal health information or IRB waiver is granted to collect study information without patient consent
Exclusion criteria
There are no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endpoint 1: Procedural Success Endpoint 2: Progression-Free Survival Endpoint 3: Overall Survival Endpoint 4: Karnofsky performance status | up to 24 months | Retrospective data collection. |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events | up to 24 months |
Countries
United States