Laser Ablation in Stereotactic Neurosurgery (LAISE): NeuroBlate® Retrospective Registry
1 other identifier
observational
144
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2015
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 10, 2015
CompletedFirst Posted
Study publicly available on registry
March 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedApril 12, 2024
August 1, 2021
1.5 years
March 10, 2015
April 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Endpoint 1: Procedural Success Endpoint 2: Progression-Free Survival Endpoint 3: Overall Survival Endpoint 4: Karnofsky performance status
Retrospective data collection.
up to 24 months
Secondary Outcomes (1)
Adverse Events
up to 24 months
Interventions
Eligibility Criteria
Patients previously treated with NBS (up to 300)
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Monteris Medicallead
Study Sites (9)
Yale University
New Haven, Connecticut, 06520, United States
Kansas University Medical Center
Kansas City, Kansas, 66160, United States
St. Luke's Hospital
Kansas City, Missouri, 64111, United States
Washington University in St. Louis
St Louis, Missouri, 63110, United States
Wake Forest
Salem, North Carolina, 27157, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sujit Prabu, MD, PhD
M.D. Anderson Cancer Center
- PRINCIPAL INVESTIGATOR
Andrew Sloan, MD, PhD
University Hospitals Cleveland Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2015
First Posted
March 17, 2015
Study Start
February 1, 2015
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
April 12, 2024
Record last verified: 2021-08