Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System (LAANTERN)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02392078|
Recruitment Status : Recruiting
First Posted : March 18, 2015
Last Update Posted : March 13, 2020
|Condition or disease||Intervention/treatment|
|Metastatic Brain Tumor Primary Brain Tumor Epileptic/Seizure Foci Movement Disorders||Device: NeuroBlate System|
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System (LAANTERN) Prospective Registry|
|Actual Study Start Date :||October 2015|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2028|
- Safety (Reportable adverse events) [ Time Frame: up to 12 months ]Safety profile described by the NBS and surgical-related AEs
- Reason for NeuroBlate [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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
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): NCT02392078
|Contact: Alyssa Griffethfirstname.lastname@example.org|
|Contact: Beth Larson-DeBruzzi||763-253-4710 ext email@example.com|
|Principal Investigator:||Eric Leuthardt, MD||Washington University School of Medicine|