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Trial record 1 of 2 for:    LAISE
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Laser Ablation in Stereotactic Neurosurgery (LAISE): NeuroBlate® Retrospective Registry

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Monteris Medical
ClinicalTrials.gov Identifier:
NCT02389855
First received: March 10, 2015
Last updated: January 31, 2017
Last verified: January 2017
  Purpose
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 Intervention
Primary Brain Tumor
Procedure: NeuroBlate® System Therapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Laser Ablation in Stereotactic Neurosurgery

Further study details as provided by Monteris Medical:

Primary Outcome Measures:
  • 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:
  • Adverse Events [ Time Frame: up to 24 months ]

Enrollment: 144
Study Start Date: February 2015
Study Completion Date: August 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02389855

Locations
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
Principal Investigator: Sujit Prabu, MD, PhD M.D. Anderson Cancer Center
Principal Investigator: Andrew Sloan, MD, PhD University Hospitals Cleveland Medical Center
  More Information

Responsible Party: Monteris Medical
ClinicalTrials.gov Identifier: NCT02389855     History of Changes
Other Study ID Numbers: LAISE
Study First Received: March 10, 2015
Last Updated: January 31, 2017

Keywords provided by Monteris Medical:
Progression
Quality of Life

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 25, 2017