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

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ClinicalTrials.gov Identifier: NCT02389855
Recruitment Status : Completed
First Posted : March 17, 2015
Last Update Posted : February 2, 2017
Sponsor:
Information provided by (Responsible Party):
Monteris Medical

Study Description
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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.

Condition or disease Intervention/treatment
Primary Brain Tumor Procedure: NeuroBlate® System Therapy

Study Design
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Study Type : Observational
Actual Enrollment : 144 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Laser Ablation in Stereotactic Neurosurgery
Study Start Date : February 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Adverse Events [ Time Frame: up to 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients previously treated with NBS (up to 300)
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02389855


Locations
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United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06520
United States, Kansas
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
United States, Missouri
St. Luke's Hospital
Kansas City, Missouri, United States, 64111
Washington University in St. Louis
St. Louis, Missouri, United States, 63110
United States, North Carolina
Wake Forest
Salem, North Carolina, United States, 27157
United States, Ohio
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Monteris Medical
Investigators
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Principal Investigator: Sujit Prabu, MD, PhD M.D. Anderson Cancer Center
Principal Investigator: Andrew Sloan, MD, PhD University Hospitals Cleveland Medical Center
More Information
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Responsible Party: Monteris Medical
ClinicalTrials.gov Identifier: NCT02389855    
Other Study ID Numbers: LAISE
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: January 2017
Keywords provided by Monteris Medical:
Progression
Quality of Life
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
 Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases