Epileptic/Seizure Foci, Metastatic Brain Tumor, Movement Disorders, Primary Brain Tumor
Conditions
Keywords
Procedural Success, Progression, Quality of Life, Seizure Freedom, Progression Free Survival, Overall Survival
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 3,000 patients and up to 50 sites.
Interventions
DEVICENeuroBlate System
Sponsors
Monteris Medical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Subject or legally authorized representative provides written authorization and/or consent 2. Subject who is to undergo thermal therapy by the NeuroBlate® System for treatment of their neurological disorder
Exclusion criteria
1. Subject who is, or is expected to be inaccessible for follow-up 2. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety (Reportable Adverse Events) | up to 5 years or last follow up | 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 Seizure Freedom (ENGEL and ILAE Classifications) | up to 5 years or last follow up | 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. |
| Change in Quality of Life | up to 5 years or last follow-up | Assessed with following questionnaires: 1. KPS (malignancy subjects only) Scale range 0-100 measuring the ability of patients with cancer to perform ordinary daily activities. Score 0 is dead, 100 is no disease symptoms 2. FACT-Br (malignancy subjects only) Measure general quality of life across 5 scales- physical well-being, social/family well-being, emotional well-being, functional well-being & other. Higher score, better quality of life. Range 0-200 3. EQ-5D (tumor/epilepsy subjects only) Measure of health consisting of the descriptive system & the visual analogue scale (VAS). The system assesses subject mobility, self-care, usual activities, pain/discomfort & anxiety/depression. Higher score, better quality of life. Range 0-100 4. QOLIE-31 (epilepsy subjects only) 7 scales assessing emotional well-being, social functioning, energy/fatigue, cognitive functioning, seizure worry, medication effects, & overall quality of life. Higher score, better quality of life. Range 0-100 |
| Number of Patients Demonstrating Local Control and Overall Survival | up to 5 years 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Metastatic Tumor All eligible study subjects who presented with a metastatic brain tumor. | 342 |
| Primary Tumor All eligible study subjects who presented with a primary brain tumor. | 445 |
| Epilepsy All eligible study subjects who presented with epilepsy or seizure foci. | 268 |
| Movement Disorder All eligible study subjects who presented with a movement disorder. | 2 |
| Total | 1,057 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Did not have procedure | 32 | 43 | 20 | 1 |
Baseline characteristics
| Characteristic | Metastatic Tumor | Primary Tumor | Epilepsy | Movement Disorder | Total |
|---|---|---|---|---|---|
| Age, Customized | 61.9 years | 53.7 years | 33.9 years | 66.9 years | 54.7 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 23 Participants | 37 Participants | 0 Participants | 74 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 325 Participants | 416 Participants | 225 Participants | 2 Participants | 968 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 6 Participants | 6 Participants | 0 Participants | 15 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 9 Participants | 5 Participants | 0 Participants | 18 Participants |
| Race (NIH/OMB) Black or African American | 39 Participants | 19 Participants | 21 Participants | 0 Participants | 79 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 5 Participants | 0 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 9 Participants | 15 Participants | 0 Participants | 32 Participants |
| Race (NIH/OMB) White | 288 Participants | 406 Participants | 222 Participants | 2 Participants | 918 Participants |
| Region of Enrollment United States | 342 participants | 445 participants | 268 participants | 2 participants | 1057 participants |
| Sex: Female, Male Female | 205 Participants | 191 Participants | 139 Participants | 1 Participants | 536 Participants |
| Sex: Female, Male Male | 137 Participants | 254 Participants | 129 Participants | 1 Participants | 521 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 367 / 1,057 |
| other Total, other adverse events | 169 / 1,057 |
| serious Total, serious adverse events | 31 / 1,057 |
Outcome results
Primary
Change in Quality of Life
Assessed with following questionnaires: 1. KPS (malignancy subjects only) Scale range 0-100 measuring the ability of patients with cancer to perform ordinary daily activities. Score 0 is dead, 100 is no disease symptoms 2. FACT-Br (malignancy subjects only) Measure general quality of life across 5 scales- physical well-being, social/family well-being, emotional well-being, functional well-being & other. Higher score, better quality of life. Range 0-200 3. EQ-5D (tumor/epilepsy subjects only) Measure of health consisting of the descriptive system & the visual analogue scale (VAS). The system assesses subject mobility, self-care, usual activities, pain/discomfort & anxiety/depression. Higher score, better quality of life. Range 0-100 4. QOLIE-31 (epilepsy subjects only) 7 scales assessing emotional well-being, social functioning, energy/fatigue, cognitive functioning, seizure worry, medication effects, & overall quality of life. Higher score, better quality of life. Range 0-100
Time frame: up to 5 years or last follow-up
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Number of Participants | Change in Quality of Life | KPS | 90 score on a scale |
| Number of Participants | Change in Quality of Life | FACT Br | 149 score on a scale |
| Number of Participants | Change in Quality of Life | EQ-5D | 80 score on a scale |
| Primary Brain Tumor | Change in Quality of Life | FACT Br | 149 score on a scale |
| Primary Brain Tumor | Change in Quality of Life | EQ-5D | 80 score on a scale |
| Primary Brain Tumor | Change in Quality of Life | KPS | 80 score on a scale |
| Epileptic/Seizure Foci | Change in Quality of Life | QOLIE-31 | 65.3 score on a scale |
| Epileptic/Seizure Foci | Change in Quality of Life | EQ-5D | 80 score on a scale |
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.
Time frame: up to 5 years or last follow up
Population: Data not collected for various cohorts because they were not applicable to the end points associated with those cohorts disease state.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Number of Participants | Number of Patients Demonstrating Local Control and Overall Survival | Local Control: Median time from procedure to tumor progression (years) | 3.44 Median (in years) |
| Number of Participants | Number of Patients Demonstrating Local Control and Overall Survival | Overall Survival: Median time from diagnosis to death (years) | 4.69 Median (in years) |
| Primary Brain Tumor | Number of Patients Demonstrating Local Control and Overall Survival | Local Control: Median time from procedure to tumor progression (years) | 3.26 Median (in years) |
| Primary Brain Tumor | Number of Patients Demonstrating Local Control and Overall Survival | Overall Survival: Median time from diagnosis to death (years) | 4.27 Median (in years) |
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.
Time frame: up to 5 years or last follow up
Population: Data not collected for various cohorts because they were not applicable to the end points associated with those cohorts disease state.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Epileptic/Seizure Foci | Number of Patients Demonstrating Seizure Freedom (ENGEL and ILAE Classifications) | ILAE 2 | 25 Participants |
| Epileptic/Seizure Foci | Number of Patients Demonstrating Seizure Freedom (ENGEL and ILAE Classifications) | ENGEL I | 88 Participants |
| Epileptic/Seizure Foci | Number of Patients Demonstrating Seizure Freedom (ENGEL and ILAE Classifications) | ENGEL II | 34 Participants |
| Epileptic/Seizure Foci | Number of Patients Demonstrating Seizure Freedom (ENGEL and ILAE Classifications) | ENGEL III | 29 Participants |
| Epileptic/Seizure Foci | Number of Patients Demonstrating Seizure Freedom (ENGEL and ILAE Classifications) | ENGEL IV | 21 Participants |
| Epileptic/Seizure Foci | Number of Patients Demonstrating Seizure Freedom (ENGEL and ILAE Classifications) | ENGEL Not Provided | 96 Participants |
| Epileptic/Seizure Foci | Number of Patients Demonstrating Seizure Freedom (ENGEL and ILAE Classifications) | ILAE 1 | 58 Participants |
| Epileptic/Seizure Foci | Number of Patients Demonstrating Seizure Freedom (ENGEL and ILAE Classifications) | ILAE 3 | 31 Participants |
| Epileptic/Seizure Foci | Number of Patients Demonstrating Seizure Freedom (ENGEL and ILAE Classifications) | ILAE 4 | 36 Participants |
| Epileptic/Seizure Foci | Number of Patients Demonstrating Seizure Freedom (ENGEL and ILAE Classifications) | ILAE 5 | 16 Participants |
| Epileptic/Seizure Foci | Number of Patients Demonstrating Seizure Freedom (ENGEL and ILAE Classifications) | ILAE 6 | 4 Participants |
| Epileptic/Seizure Foci | Number of Patients Demonstrating Seizure Freedom (ENGEL and ILAE Classifications) | ILAE Not Provided | 98 Participants |
Primary
Reason for NeuroBlate
To identify the primary reason the NeuroBlate system was chosen for subject
Time frame: Index procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Number of Participants | Reason for NeuroBlate | Minimally Invasive Preferred | 702 participants |
| Number of Participants | Reason for NeuroBlate | Non-Resectable | 186 participants |
| Number of Participants | Reason for NeuroBlate | Subject exceeded max dose or could not tolerate radiation | 24 participants |
| Number of Participants | Reason for NeuroBlate | Subject not a candidate for craniotomy | 31 participants |
| Number of Participants | Reason for NeuroBlate | Palliative | 7 participants |
| Number of Participants | Reason for NeuroBlate | Other | 139 participants |
| Number of Participants | Reason for NeuroBlate | Unknown | 37 participants |
Primary
Safety (Reportable Adverse Events)
Safety profile described by the NBS and surgical-related AEs
Time frame: up to 5 years or last follow up
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Number of Participants | Safety (Reportable Adverse Events) | Anxiety | 1 Participants |
| Number of Participants | Safety (Reportable Adverse Events) | Hypertension | 1 Participants |
| Number of Participants | Safety (Reportable Adverse Events) | None | 888 Participants |
| Number of Participants | Safety (Reportable Adverse Events) | Aphasia | 7 Participants |
| Number of Participants | Safety (Reportable Adverse Events) | Ataxia or loss of body coordination | 2 Participants |
| Number of Participants | Safety (Reportable Adverse Events) | Bleeding or increased risk of bleeding into or around the brain | 30 Participants |
| Number of Participants | Safety (Reportable Adverse Events) | Blurry vision/visual disturbance/Permanent neuro deficit | 3 Participants |
| Number of Participants | Safety (Reportable Adverse Events) | Cerebral edema/Edema | 21 Participants |
| Number of Participants | Safety (Reportable Adverse Events) | Cerebral infarction | 1 Participants |
| Number of Participants | Safety (Reportable Adverse Events) | Complete or incomplete hemiparesis | 2 Participants |
| Number of Participants | Safety (Reportable Adverse Events) | Deep venous thrombsois | 2 Participants |
| Number of Participants | Safety (Reportable Adverse Events) | Difficulty speaking | 5 Participants |
| Number of Participants | Safety (Reportable Adverse Events) | Difficulty walking | 3 Participants |
| Number of Participants | Safety (Reportable Adverse Events) | Headache | 3 Participants |
| Number of Participants | Safety (Reportable Adverse Events) | Infection or increased risk of infection, local or generalized | 6 Participants |
| Number of Participants | Safety (Reportable Adverse Events) | Injury to brain tissue | 2 Participants |
| Number of Participants | Safety (Reportable Adverse Events) | Muscle weakness | 15 Participants |
| Number of Participants | Safety (Reportable Adverse Events) | Nausea/vomiting | 1 Participants |
| Number of Participants | Safety (Reportable Adverse Events) | Nerve Paralysis/Paralysis | 3 Participants |
| Number of Participants | Safety (Reportable Adverse Events) | Personality or cognitive changes (e.g. mood, memory, attention and thinking ability) | 3 Participants |
| Number of Participants | Safety (Reportable Adverse Events) | Pneumonia | 3 Participants |
| Number of Participants | Safety (Reportable Adverse Events) | Pulmonary or other air embolism | 7 Participants |
| Number of Participants | Safety (Reportable Adverse Events) | Seizure/Increased seizures frequency, duration or severity | 19 Participants |
| Number of Participants | Safety (Reportable Adverse Events) | Status epilepticus | 1 Participants |
| Number of Participants | Safety (Reportable Adverse Events) | Stroke or transient ischemic attack (TIA) | 2 Participants |
| Number of Participants | Safety (Reportable Adverse Events) | Tingling or numb sensations in the body | 1 Participants |
| Number of Participants | Safety (Reportable Adverse Events) | Wound dehiscence | 2 Participants |
| Number of Participants | Safety (Reportable Adverse Events) | Other | 23 Participants |