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

• Sponsor: Monteris Medical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02389855
• Collaborator: (none)
• Enrollment: 144
• Locations: 9
• Duration (Months): 18
• Patients Per Site: 16
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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	Phase
Primary Brain Tumor	Procedure: NeuroBlate® System Therapy

Study Design

• Study Type: Observational
• Actual Enrollment: 144 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Laser Ablation in Stereotactic Neurosurgery
• Study Start Date: Feb 1, 2015
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Aug 1, 2016

Outcome Measures

Primary Outcome Measures

1. Endpoint 1: Procedural Success Endpoint 2: Progression-Free Survival Endpoint 3: Overall Survival Endpoint 4: Karnofsky performance status [up to 24 months]

   Retrospective data collection.

Secondary Outcome Measures

1. Adverse Events [up to 24 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts 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 exclusion criteria for this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale University	New Haven	Connecticut	United States	06520
2	Kansas University Medical Center	Kansas City	Kansas	United States	66160
3	St. Luke's Hospital	Kansas City	Missouri	United States	64111
4	Washington University in St. Louis	Saint Louis	Missouri	United States	63110
5	Wake Forest	Salem	North Carolina	United States	27157
6	University Hospitals Cleveland Medical Center	Cleveland	Ohio	United States	44106
7	Cleveland Clinic	Cleveland	Ohio	United States	44195
8	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107
9	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Monteris Medical
• ClinicalTrials.gov Identifier: NCT02389855
• Other Study ID Numbers: LAISE
• First Posted: Mar 17, 2015
• Last Update Posted: Aug 24, 2021
• Last Verified: Aug 1, 2021

• Keywords provided by Monteris Medical: Progression; Quality of Life
• Additional relevant MeSH terms: Brain Neoplasms

Study Results

No Results Posted as of Aug 24, 2021