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

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.

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Key information

Conditions

Primary Brain Tumor Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Disease Attributes Disease Progression Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Yale University, New Haven, Connecticut, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NeuroBlate® System Therapy

Procedure

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

Retrospective data collection.

Secondary outcomes

Adverse Events

Time frame: up to 24 months

Sponsors and collaborators

Lead sponsor

Monteris Medical

Industry

Registry information

Official study title

Laser Ablation in Stereotactic Neurosurgery

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Mar 17, 2015
Registry last updated: Apr 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed