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

NCT ID: NCT02389855

Last Updated: 2024-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

144 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-08-31

Brief Summary

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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

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Conditions

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Primary Brain Tumor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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NeuroBlate® System Therapy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Monteris Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sujit Prabu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Andrew Sloan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

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Yale University

New Haven, Connecticut, United States

Site Status

Kansas University Medical Center

Kansas City, Kansas, United States

Site Status

St. Luke's Hospital

Kansas City, Missouri, United States

Site Status

Washington University in St. Louis

St Louis, Missouri, United States

Site Status

Wake Forest

Salem, North Carolina, United States

Site Status

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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LAISE

Identifier Type: -

Identifier Source: org_study_id

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