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

Completed

• Conditions: Primary Brain Tumor

• Registration Number: NCT02389855
• Lead Sponsor: Monteris Medical

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-03-10
• Study First Submitted QC: 2015-03-16
• Study First Posted: 2015-03-17
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2021-08
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Adverse Events	up to 24 months

Trial Locations

Locations (9)

St. Luke's Hospital; 🇺🇸 Kansas City, Missouri, United States

Kansas University Medical Center; 🇺🇸 Kansas City, Kansas, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States

Wake Forest; 🇺🇸 Salem, North Carolina, United States

The University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States