Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 3,000 patients and up to 50 sites.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeuroBlate System | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Safety (Reportable Adverse Events) | Safety profile described by the NBS and surgical-related AEs | up to 5 years or last follow up |
| Reason for NeuroBlate | To identify the primary reason the NeuroBlate system was chosen for subject | Index procedure |
| Number of Patients Demonstrating Seizure Freedom (ENGEL and ILAE Classifications) | Collected for all subjects by disease etiology. 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 (best), Class II, Class III, Class IV (worst)) categorized by severity. The ILAE outcome scale contains six classes (Class 1 (best), 2, 3, 4, 5, 6 (worst)) categorized by severity. | up to 5 years or last follow up |
| Change in Quality of Life | Assessed with following questionnaires:
| up to 5 years or last follow-up |
| Number of Patients Demonstrating Local Control and Overall Survival |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Subjects who present with a brain lesion, epileptic/seizure foci, or movement disorder who have been deemed appropriate candidates, in the opinion of the treating physician, for laser ablation using the NeuroBlate® System.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eric Leuthardt, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrow Neurological Institute at Dignity Health St. Joseph's Hospital & Medical Center | Phoenix | Arizona | 85013 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33045664 | Derived | Landazuri P, Shih J, Leuthardt E, Ben-Haim S, Neimat J, Tovar-Spinoza Z, Chiang V, Spencer D, Sun D, Fecci P, Baumgartner J. A prospective multicenter study of laser ablation for drug resistant epilepsy - One year outcomes. Epilepsy Res. 2020 Nov;167:106473. doi: 10.1016/j.eplepsyres.2020.106473. Epub 2020 Sep 22. | |
| 32315434 | Derived |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Metastatic Brain Tumor | All eligible study subjects who presented with a metastatic brain tumor. |
| FG001 | Primary Brain Tumor | All eligible study subjects who presented with a primary brain tumor. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 23, 2022 | Mar 13, 2025 |
Not provided
Not provided
Not provided
Collected for all subjects by disease etiology. Local control as measured by time to local tumor recurrence. Overall survival assessed by Kaplan-Meier method. |
| up to 5 years or last follow up |
| University of Arkansas for Medical Sciences |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| University of California, San Diego | La Jolla | California | 92093 | United States |
| Children's Hospital of Orange County | Orange | California | 92868 | United States |
| Yale University School of Medicine | New Haven | Connecticut | 06510 | United States |
| Advent Health Orlando | Orlando | Florida | 32804 | United States |
| Johns Hopkins All Children's Hospital | St. Petersburg | Florida | 33701 | United States |
| The Cleveland Clinic Florida | Weston | Florida | 33331 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| University of Louisville | Louisville | Kentucky | 40208 | United States |
| Norton Cancer Institute | Louisville | Kentucky | 40241 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| United Children's Hospital St. Paul | Saint Paul | Minnesota | 55102 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| New York University Langone Medical Center | New York | New York | 10016 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Wake Forest | Winston-Salem | North Carolina | 27157 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Saint Thomas West Hospital and Research Institute | Nashville | Tennessee | 37205 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| MD Anderson | Houston | Texas | 77030 | United States |
| Kim AH, Tatter S, Rao G, Prabhu S, Chen C, Fecci P, Chiang V, Smith K, Williams BJ, Mohammadi AM, Judy K, Sloan A, Tovar-Spinoza Z, Baumgartner J, Hadjipanayis C, Leuthardt EC. Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System (LAANTERN): 12-Month Outcomes and Quality of Life After Brain Tumor Ablation. Neurosurgery. 2020 Sep 1;87(3):E338-E346. doi: 10.1093/neuros/nyaa071. |
| 31076762 | Derived | Rennert RC, Khan U, Bartek J, Tatter SB, Field M, Toyota B, Fecci PE, Judy K, Mohammadi AM, Landazuri P, Sloan AE, Kim AH, Leuthardt EC, Chen CC. Laser Ablation of Abnormal Neurological Tissue Using Robotic Neuroblate System (LAANTERN): Procedural Safety and Hospitalization. Neurosurgery. 2020 Apr 1;86(4):538-547. doi: 10.1093/neuros/nyz141. |
| FG002 | Epileptic/Seizure Foci | All eligible study subjects who presented with epilepsy or seizure foci. |
| FG003 | Movement Disorders | All eligible study subjects who presented with a movement disorder. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
1057 subjects total across 4 cohorts- 268 Epilepsy, 2 Movement disorders, 445 Primary brain tumors and 342 Metastatic brain tumors for a total of 1057.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Metastatic Tumor | All eligible study subjects who presented with a metastatic brain tumor. |
| BG001 | Primary Tumor | All eligible study subjects who presented with a primary brain tumor. |
| BG002 | Epilepsy | All eligible study subjects who presented with epilepsy or seizure foci. |
| BG003 | Movement Disorder | All eligible study subjects who presented with a movement disorder. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety (Reportable Adverse Events) | Safety profile described by the NBS and surgical-related AEs | Posted | Count of Participants | Participants | No | up to 5 years or last follow up |
|
|
| ||||||||||||||||||||||||||||||
| Primary | Reason for NeuroBlate | To identify the primary reason the NeuroBlate system was chosen for subject | Posted | Number | participants | Index procedure |
|
|
| |||||||||||||||||||||||||||||||
| Primary | Number of Patients Demonstrating Seizure Freedom (ENGEL and ILAE Classifications) | Collected for all subjects by disease etiology. 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 (best), Class II, Class III, Class IV (worst)) categorized by severity. The ILAE outcome scale contains six classes (Class 1 (best), 2, 3, 4, 5, 6 (worst)) categorized by severity. | Data not collected for various cohorts because they were not applicable to the end points associated with those cohorts disease state. | Posted | Count of Participants | Participants | No | up to 5 years or last follow up |
| |||||||||||||||||||||||||||||||
| Primary | Change in Quality of Life | Assessed with following questionnaires:
| The questionnaires are only applicable to certain cohorts in the study population and were not collected or analyzed for subjects who were not in that cohort. | Posted | Median | Full Range | score on a scale | up to 5 years or last follow-up |
| |||||||||||||||||||||||||||||||
| Primary | Number of Patients Demonstrating Local Control and Overall Survival | Collected for all subjects by disease etiology. Local control as measured by time to local tumor recurrence. Overall survival assessed by Kaplan-Meier method. | Data not collected for various cohorts because they were not applicable to the end points associated with those cohorts disease state. | Posted | Median | 95% Confidence Interval | Median (in years) | up to 5 years or last follow up |
|
Adverse events were collected from the time of patient consent (prior to the surgical procedure) to study withdraw/completion which varied for each subject, but up to 5 years. From time of consent to withdraw varied based on death or study withdraw. Adverse events were monitored throughout the subjects study participation.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Number of Participants With Adverse Events | All eligible study subjects who underwent LITT with the NeuroBlate System. | 367 | 1,057 | 31 | 1,057 | 169 | 1,057 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aphasia | Nervous system disorders | Systematic Assessment |
| ||
| Bleeding or increased bleeding around the brain | Nervous system disorders | Systematic Assessment |
| ||
| Cerebral edema | Nervous system disorders | Systematic Assessment |
| ||
| Edema | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Infection or increased risk of infection | Infections and infestations | Systematic Assessment |
| ||
| Muscle Weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Nerve paralysis | Nervous system disorders | Systematic Assessment |
| ||
| Pulmonary or other air embolism | Cardiac disorders | Systematic Assessment |
| ||
| Seizures | Nervous system disorders | Systematic Assessment |
| ||
| Status epilepticus | Nervous system disorders | Systematic Assessment |
| ||
| Stroke or transient ischemic attack | Cardiac disorders | Systematic Assessment |
| ||
| Other | General disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Aphasia | Nervous system disorders | Systematic Assessment |
| ||
| Ataxia or loss of body coordination | Nervous system disorders | Systematic Assessment |
| ||
| Bleeding or increased risk of bleeding around the brain | Nervous system disorders | Systematic Assessment |
| ||
| Blurry vision/visual disturbance | Nervous system disorders | Systematic Assessment |
| ||
| Cerebral edema/Edema | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Cerebral infarction | Nervous system disorders | Systematic Assessment |
| ||
| Complete or incomplete hemiparesis | Nervous system disorders | Systematic Assessment |
| ||
| Deep venous thrombosis | Cardiac disorders | Systematic Assessment |
| ||
| Difficulty speaking | Nervous system disorders | Systematic Assessment |
| ||
| Difficulty walking | Nervous system disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Infection or increased risk of infection | Infections and infestations | Systematic Assessment |
| ||
| Injury to brain tissue | Nervous system disorders | Systematic Assessment |
| ||
| Muscle weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Nausea/vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nerve paralysis/paralysis | Nervous system disorders | Systematic Assessment |
| ||
| Personality or cognitive changes | Psychiatric disorders | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Pulmonary or air embolism | Cardiac disorders | Systematic Assessment |
| ||
| Seizure/increased seizures frequency, duration, or severity | Nervous system disorders | Systematic Assessment |
| ||
| Status epilepticus | Nervous system disorders | Systematic Assessment |
| ||
| Stroke or transient ischemic attack | Cardiac disorders | Systematic Assessment |
| ||
| Tingling or numb sensations in the body | Nervous system disorders | Systematic Assessment |
| ||
| Wound dehiscence | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Other | General disorders | Systematic Assessment |
| ||
| Hypertension | Cardiac disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christa Seligman | Monteris Medical | (952) 463-7747 | cseligman@monteris.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 1, 2020 | Mar 13, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D004827 | Epilepsy |
| D009069 | Movement Disorders |
| D018450 | Disease Progression |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Bleeding or increased risk of bleeding into or around the brain |
|
| Blurry vision/visual disturbance/Permanent neuro deficit |
|
| Cerebral edema/Edema |
|
| Cerebral infarction |
|
| Complete or incomplete hemiparesis |
|
| Deep venous thrombsois |
|
| Difficulty speaking |
|
| Difficulty walking |
|
| Headache |
|
| Infection or increased risk of infection, local or generalized |
|
| Injury to brain tissue |
|
| Muscle weakness |
|
| Nausea/vomiting |
|
| Nerve Paralysis/Paralysis |
|
| Personality or cognitive changes (e.g. mood, memory, attention and thinking ability) |
|
| Pneumonia |
|
| Pulmonary or other air embolism |
|
| Seizure/Increased seizures frequency, duration or severity |
|
| Status epilepticus |
|
| Stroke or transient ischemic attack (TIA) |
|
| Tingling or numb sensations in the body |
|
| Wound dehiscence |
|
| Other |
|
| Hypertension |
|
| None |
|
| Minimally Invasive Preferred |
| |||||
| Non-Resectable |
| |||||
| Subject exceeded max dose or could not tolerate radiation |
| |||||
| Subject not a candidate for craniotomy |
| |||||
| Palliative |
| |||||
| Other |
| |||||
| Unknown |
|
All eligible study subjects who presented with a movement disorder. |
|
|
| OG002 | Epileptic/Seizure Foci | All eligible study subjects who presented with epilepsy or seizure foci. |
| OG003 | Movement Disorders | All eligible study subjects who presented with a movement disorder. |
|
|
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|