LAANTERN: Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System

Sponsor

Monteris Medical (Industry)

Overall Status

Recruiting

CT.gov ID

NCT02392078

Collaborator

(none)

3,000

Enrollment

Locations

242

Anticipated Duration (Months)

103.4

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The NeuroBlate® System (NBS) is a minimally invasive robotic laser thermotherapy tool that is being manufactured by Monteris Medical. Since it received FDA clearance in May 2009, the NBS has been used in over 2600 procedures conducted at over 70 leading institutions across United States. This is a prospective, multi-center registry that will include data collection up to 5 years to evaluate safety, QoL, and procedural outcomes including local control failure rate, progression free survival, overall survival, and seizure freedom in up to 1,000 patients and up to 50 sites.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Brain Tumor Primary Brain Tumor Epileptic/Seizure Foci Movement Disorders	Device: NeuroBlate System

Study Design

Study Type:

Observational

Anticipated Enrollment :

3000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System (LAANTERN) Prospective Registry

Actual Study Start Date :

Oct 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2030

Anticipated Study Completion Date :

Dec 1, 2035

Outcome Measures

Primary Outcome Measures

Safety (Reportable adverse events) [up to 12 months]
Safety profile described by the NBS and surgical-related AEs
Reason for NeuroBlate [Index procedure]
To identify the primary reason the NeuroBlate system was chosen for subject
Number of patients demonstrating local control, overall survival, and seizure freedom (ENGEL and ILAE classifications) [up to 12 months or last follow-up]
Collected for all subjects by disease etiology. Local control as measured by time to local tumor recurrence. Overall survival assessed by Kaplan-Meier method. Seizure freedom assessed for all subjects with epilepsy at time of last follow-up. The ENGEL surgical outcome scale is composed of four classes of epilepsy (Class I, Class II, Class III, Class IV) categorized by severity. The ILAE outcome scale contains six classes (Class 1, 2, 3, 4, 5, 6) categorized by severity.
Change in Quality of Life [up to 12 months or last follow-up]
Assessed by the following questionnaires: KPS (subjects with CNS malignancy): Scale ranged 0-100 measuring the ability of patients with cancer to perform ordinary daily activities FACT-Br (subjects with CNS malignancy): Measures general quality of life reflecting symptoms associated with brain malignancies across 5 scales (physical well-being social/family well-being, emotional well-being, functional well-being, and other) EQ-5D (all subjects): A generic measure of health consisting of the descriptive system and the visual analogue scale (VAS). The descriptive system assesses subject mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The VAS reports the subject's self-rated health QOLIE-31 (subjects with epilepsy): Contains 7 scales assessing emotional well-being, social functioning, energy/fatigue, cognitive functioning, seizure worry, medication effects, and overall quality of life for adults

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subject or legally authorized representative provides written authorization and/or consent
Subject who is to undergo thermal therapy by the NeuroBlate® System for treatment of their neurological disorder

Exclusion Criteria:

Subject who is, or is expected to be inaccessible for follow-up
Other concurrent medical or other condition (chronic or acute in nature) that in the opinion of the investigator, may prevent participation or otherwise render subject ineligibility for the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Barrow Neurological Institute at Dignity Health St. Joseph's Hospital & Medical Center	Phoenix	Arizona	United States	85013
2	University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
3	University of California, San Diego	La Jolla	California	United States	92093
4	Children's Hospital of Orange County	Orange	California	United States	92868
5	Yale University School of Medicine	New Haven	Connecticut	United States	06510
6	Advent Health Orlando	Orlando	Florida	United States	32804
7	The Cleveland Clinic Florida	Weston	Florida	United States	33331
8	Northwestern University	Chicago	Illinois	United States	60611
9	University of Kansas Medical Center	Kansas City	Kansas	United States	66160
10	University of Louisville	Louisville	Kentucky	United States	40208
11	Norton Cancer Institute	Louisville	Kentucky	United States	40241
12	University of Minnesota	Minneapolis	Minnesota	United States	55455
13	United Children's Hospital St. Paul	Saint Paul	Minnesota	United States	55102
14	Washington University	Saint Louis	Missouri	United States	63110
15	New York University Langone Medical Center	New York	New York	United States	10016
16	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029
17	Weill Cornell Medicine	New York	New York	United States	10065
18	SUNY Upstate Medical University	Syracuse	New York	United States	13210
19	Duke University Medical Center	Durham	North Carolina	United States	27710
20	Wake Forest	Winston-Salem	North Carolina	United States	27157
21	University Hospitals Cleveland Medical Center	Cleveland	Ohio	United States	44106
22	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
23	Geisinger Medical Center	Danville	Pennsylvania	United States	17822
24	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107
25	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
26	Saint Thomas West Hospital and Research Institute	Nashville	Tennessee	United States	37205
27	University of Texas Southwestern Medical Center	Dallas	Texas	United States	75390
28	MD Anderson	Houston	Texas	United States	77030
29	University of British Columbia	Vancouver	British Columbia	Canada	V5Z 1M9