This trial has been completed.

Condition primary brain tumor
Treatment neuroblate® system therapy
Sponsor Monteris Medical
Start date February 2015
End date August 2016
Trial size 144 participants
Trial identifier NCT02389855, LAISE


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective

Primary Outcomes

Endpoint 1: Procedural Success Endpoint 2: Progression-Free Survival Endpoint 3: Overall Survival Endpoint 4: Karnofsky performance status
time frame: up to 24 months

Secondary Outcomes

Adverse Events
time frame: up to 24 months

Eligibility Criteria

All participants of any age.

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 exclusion criteria for this study.

Additional Information

Official title Laser Ablation in Stereotactic Neurosurgery
Principal investigator Sujit Prabu, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by Monteris Medical.