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

Laser Ablation in Stereotactic Neurosurgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02389855
Enrollment
144
Registered
2015-03-17
Start date
2015-02-28
Completion date
2016-08-31
Last updated
2024-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Brain Tumor

Keywords

Progression, Quality of Life

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.

Interventions

PROCEDURENeuroBlate® System Therapy

Sponsors

Monteris Medical
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Endpoint 1: Procedural Success Endpoint 2: Progression-Free Survival Endpoint 3: Overall Survival Endpoint 4: Karnofsky performance statusup to 24 monthsRetrospective data collection.

Secondary

MeasureTime frame
Adverse Eventsup to 24 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026