Laser Ablation in Stereotactic Neurosurgery (LAISE): NeuroBlate® Retrospective Registry

Monteris Medical144 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

144

Conditions

Primary Brain Tumor

Interventions

NeuroBlate® System TherapyPROCEDURE

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (9)

Yale University

New Haven, Connecticut, United States

Kansas University Medical Center

Kansas City, Kansas, United States

St. Luke's Hospital

Kansas City, Missouri, United States

Washington University in St. Louis

Outcomes

Primary Outcomes

Endpoint 1: Procedural Success Endpoint 2: Progression-Free Survival Endpoint 3: Overall Survival Endpoint 4: Karnofsky performance status

Retrospective data collection.

Time frame: up to 24 months

Secondary Outcomes

Adverse Events

Time frame: up to 24 months

Data from ClinicalTrials.gov

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