Trial Outcomes & Findings for Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System (NCT NCT02392078)

NCT ID: NCT02392078

Last Updated: 2025-04-24

Results Overview

Safety profile described by the NBS and surgical-related AEs

• Recruitment status: COMPLETED
• Target enrollment: 1153 participants
• Primary outcome timeframe: up to 5 years or last follow up
• Results posted on: 2025-04-24

Participant Flow

Participant milestones

Measure	Metastatic Brain Tumor All eligible study subjects who presented with a metastatic brain tumor.	Primary Brain Tumor All eligible study subjects who presented with a primary brain tumor.	Epileptic/Seizure Foci All eligible study subjects who presented with epilepsy or seizure foci.	Movement Disorders All eligible study subjects who presented with a movement disorder.
Overall Study STARTED	374	488	288	3
Overall Study COMPLETED	342	445	268	2
Overall Study NOT COMPLETED	32	43	20	1

Reasons for withdrawal

Measure	Metastatic Brain Tumor All eligible study subjects who presented with a metastatic brain tumor.	Primary Brain Tumor All eligible study subjects who presented with a primary brain tumor.	Epileptic/Seizure Foci All eligible study subjects who presented with epilepsy or seizure foci.	Movement Disorders All eligible study subjects who presented with a movement disorder.
Overall Study Did not have procedure	32	43	20	1

Baseline Characteristics

Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System

Baseline characteristics by cohort

Measure	Metastatic Tumor n=342 Participants All eligible study subjects who presented with a metastatic brain tumor.	Primary Tumor n=445 Participants All eligible study subjects who presented with a primary brain tumor.	Epilepsy n=268 Participants All eligible study subjects who presented with epilepsy or seizure foci.	Movement Disorder n=2 Participants All eligible study subjects who presented with a movement disorder.	Total n=1057 Participants Total of all reporting groups
Age, Customized	61.9 years n=5 Participants	53.7 years n=7 Participants	33.9 years n=5 Participants	66.9 years n=4 Participants	54.7 years n=21 Participants
Sex: Female, Male Female	205 Participants n=5 Participants	191 Participants n=7 Participants	139 Participants n=5 Participants	1 Participants n=4 Participants	536 Participants n=21 Participants
Sex: Female, Male Male	137 Participants n=5 Participants	254 Participants n=7 Participants	129 Participants n=5 Participants	1 Participants n=4 Participants	521 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=5 Participants	23 Participants n=7 Participants	37 Participants n=5 Participants	0 Participants n=4 Participants	74 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	325 Participants n=5 Participants	416 Participants n=7 Participants	225 Participants n=5 Participants	2 Participants n=4 Participants	968 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	0 Participants n=4 Participants	15 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	9 Participants n=7 Participants	5 Participants n=5 Participants	0 Participants n=4 Participants	18 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	39 Participants n=5 Participants	19 Participants n=7 Participants	21 Participants n=5 Participants	0 Participants n=4 Participants	79 Participants n=21 Participants
Race (NIH/OMB) White	288 Participants n=5 Participants	406 Participants n=7 Participants	222 Participants n=5 Participants	2 Participants n=4 Participants	918 Participants n=21 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants	0 Participants n=4 Participants	8 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants	0 Participants n=4 Participants	32 Participants n=21 Participants
Region of Enrollment United States	342 participants n=5 Participants	445 participants n=7 Participants	268 participants n=5 Participants	2 participants n=4 Participants	1057 participants n=21 Participants

PRIMARY outcome

Timeframe: up to 5 years or last follow up

Safety profile described by the NBS and surgical-related AEs

Outcome measures

Measure	Number of Participants n=1057 Participants All eligible study subjects who underwent LITT with the NeuroBlate System.	Primary Brain Tumor All eligible study subjects who presented with a primary brain tumor.	Epileptic/Seizure Foci All eligible study subjects who presented with epilepsy or seizure foci.	Movement Disorders All eligible study subjects who presented with a movement disorder.
Safety (Reportable Adverse Events) Anxiety	1 Participants	—	—	—
Safety (Reportable Adverse Events) Aphasia	7 Participants	—	—	—
Safety (Reportable Adverse Events) Ataxia or loss of body coordination	2 Participants	—	—	—
Safety (Reportable Adverse Events) Bleeding or increased risk of bleeding into or around the brain	30 Participants	—	—	—
Safety (Reportable Adverse Events) Blurry vision/visual disturbance/Permanent neuro deficit	3 Participants	—	—	—
Safety (Reportable Adverse Events) Cerebral edema/Edema	21 Participants	—	—	—
Safety (Reportable Adverse Events) Cerebral infarction	1 Participants	—	—	—
Safety (Reportable Adverse Events) Complete or incomplete hemiparesis	2 Participants	—	—	—
Safety (Reportable Adverse Events) Deep venous thrombsois	2 Participants	—	—	—
Safety (Reportable Adverse Events) Difficulty speaking	5 Participants	—	—	—
Safety (Reportable Adverse Events) Difficulty walking	3 Participants	—	—	—
Safety (Reportable Adverse Events) Headache	3 Participants	—	—	—
Safety (Reportable Adverse Events) Infection or increased risk of infection, local or generalized	6 Participants	—	—	—
Safety (Reportable Adverse Events) Injury to brain tissue	2 Participants	—	—	—
Safety (Reportable Adverse Events) Muscle weakness	15 Participants	—	—	—
Safety (Reportable Adverse Events) Nausea/vomiting	1 Participants	—	—	—
Safety (Reportable Adverse Events) Nerve Paralysis/Paralysis	3 Participants	—	—	—
Safety (Reportable Adverse Events) Personality or cognitive changes (e.g. mood, memory, attention and thinking ability)	3 Participants	—	—	—
Safety (Reportable Adverse Events) Pneumonia	3 Participants	—	—	—
Safety (Reportable Adverse Events) Pulmonary or other air embolism	7 Participants	—	—	—
Safety (Reportable Adverse Events) Seizure/Increased seizures frequency, duration or severity	19 Participants	—	—	—
Safety (Reportable Adverse Events) Status epilepticus	1 Participants	—	—	—
Safety (Reportable Adverse Events) Stroke or transient ischemic attack (TIA)	2 Participants	—	—	—
Safety (Reportable Adverse Events) Tingling or numb sensations in the body	1 Participants	—	—	—
Safety (Reportable Adverse Events) Wound dehiscence	2 Participants	—	—	—
Safety (Reportable Adverse Events) Other	23 Participants	—	—	—
Safety (Reportable Adverse Events) Hypertension	1 Participants	—	—	—
Safety (Reportable Adverse Events) None	888 Participants	—	—	—

PRIMARY outcome

Timeframe: Index procedure

To identify the primary reason the NeuroBlate system was chosen for subject

Outcome measures

Measure	Number of Participants n=1057 Participants All eligible study subjects who underwent LITT with the NeuroBlate System.	Primary Brain Tumor All eligible study subjects who presented with a primary brain tumor.	Epileptic/Seizure Foci All eligible study subjects who presented with epilepsy or seizure foci.	Movement Disorders All eligible study subjects who presented with a movement disorder.
Reason for NeuroBlate Minimally Invasive Preferred	702 participants	—	—	—
Reason for NeuroBlate Non-Resectable	186 participants	—	—	—
Reason for NeuroBlate Subject exceeded max dose or could not tolerate radiation	24 participants	—	—	—
Reason for NeuroBlate Subject not a candidate for craniotomy	31 participants	—	—	—
Reason for NeuroBlate Palliative	7 participants	—	—	—
Reason for NeuroBlate Other	139 participants	—	—	—
Reason for NeuroBlate Unknown	37 participants	—	—	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Number of Participants n=342 Participants All eligible study subjects who underwent LITT with the NeuroBlate System.	Primary Brain Tumor n=445 Participants All eligible study subjects who presented with a primary brain tumor.	Epileptic/Seizure Foci n=268 Participants All eligible study subjects who presented with epilepsy or seizure foci.	Movement Disorders n=2 Participants All eligible study subjects who presented with a movement disorder.
Number of Patients Demonstrating Seizure Freedom (ENGEL and ILAE Classifications) ILAE 6	—	—	4 Participants	—
Number of Patients Demonstrating Seizure Freedom (ENGEL and ILAE Classifications) ILAE Not Provided	—	—	98 Participants	—
Number of Patients Demonstrating Seizure Freedom (ENGEL and ILAE Classifications) ENGEL I	—	—	88 Participants	—
Number of Patients Demonstrating Seizure Freedom (ENGEL and ILAE Classifications) ENGEL II	—	—	34 Participants	—
Number of Patients Demonstrating Seizure Freedom (ENGEL and ILAE Classifications) ENGEL III	—	—	29 Participants	—
Number of Patients Demonstrating Seizure Freedom (ENGEL and ILAE Classifications) ENGEL IV	—	—	21 Participants	—
Number of Patients Demonstrating Seizure Freedom (ENGEL and ILAE Classifications) ENGEL Not Provided	—	—	96 Participants	—
Number of Patients Demonstrating Seizure Freedom (ENGEL and ILAE Classifications) ILAE 1	—	—	58 Participants	—
Number of Patients Demonstrating Seizure Freedom (ENGEL and ILAE Classifications) ILAE 2	—	—	25 Participants	—
Number of Patients Demonstrating Seizure Freedom (ENGEL and ILAE Classifications) ILAE 3	—	—	31 Participants	—
Number of Patients Demonstrating Seizure Freedom (ENGEL and ILAE Classifications) ILAE 4	—	—	36 Participants	—
Number of Patients Demonstrating Seizure Freedom (ENGEL and ILAE Classifications) ILAE 5	—	—	16 Participants	—

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Number of Participants n=342 Participants All eligible study subjects who underwent LITT with the NeuroBlate System.	Primary Brain Tumor n=445 Participants All eligible study subjects who presented with a primary brain tumor.	Epileptic/Seizure Foci n=268 Participants All eligible study subjects who presented with epilepsy or seizure foci.	Movement Disorders n=2 Participants All eligible study subjects who presented with a movement disorder.
Change in Quality of Life KPS	90 score on a scale Interval 0.0 to 100.0	80 score on a scale Interval 10.0 to 100.0	—	—
Change in Quality of Life FACT Br	149 score on a scale Interval 49.0 to 200.0	149 score on a scale Interval 49.0 to 200.0	—	—
Change in Quality of Life EQ-5D	80 score on a scale Interval 5.0 to 100.0	80 score on a scale Interval 5.0 to 100.0	80 score on a scale Interval 1.0 to 100.0	—
Change in Quality of Life QOLIE-31	—	—	65.3 score on a scale Interval 7.0 to 96.0	—

PRIMARY outcome

Timeframe: 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.

Collected for all subjects by disease etiology.

Local control as measured by time to local tumor recurrence.

Overall survival assessed by Kaplan-Meier method.

Outcome measures

Measure	Number of Participants n=342 Participants All eligible study subjects who underwent LITT with the NeuroBlate System.	Primary Brain Tumor n=445 Participants All eligible study subjects who presented with a primary brain tumor.	Epileptic/Seizure Foci n=268 Participants All eligible study subjects who presented with epilepsy or seizure foci.	Movement Disorders n=2 Participants All eligible study subjects who presented with a movement disorder.
Number of Patients Demonstrating Local Control and Overall Survival Local Control: Median time from procedure to tumor progression (years)	3.44 Median (in years) Interval 1.7 to Upper limit is NA due to over half of the subjects still being alive at time of study exit	3.26 Median (in years) Interval 2.02 to Upper limit is NA due to over half of the subjects still being alive at time of study exit	—	—
Number of Patients Demonstrating Local Control and Overall Survival Overall Survival: Median time from diagnosis to death (years)	4.69 Median (in years) Interval 3.38 to 5.73	4.27 Median (in years) Interval 3.68 to 7.34	—	—

Adverse Events

Number of Participants With Adverse Events

Serious events: 31 serious events

Other events: 169 other events

Deaths: 367 deaths

Serious adverse events

Measure	Number of Participants With Adverse Events n=1057 participants at risk All eligible study subjects who underwent LITT with the NeuroBlate System.
Nervous system disorders Aphasia	0.09% 1/1057 • Number of events 1 • 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.
Nervous system disorders Bleeding or increased bleeding around the brain	0.66% 7/1057 • Number of events 7 • 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.
Nervous system disorders Cerebral edema	0.19% 2/1057 • Number of events 2 • 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.
Blood and lymphatic system disorders Edema	0.19% 2/1057 • Number of events 2 • 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.
Nervous system disorders Headache	0.09% 1/1057 • Number of events 1 • 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.
Infections and infestations Infection or increased risk of infection	0.19% 2/1057 • Number of events 2 • 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.
Musculoskeletal and connective tissue disorders Muscle Weakness	0.28% 3/1057 • Number of events 3 • 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.
Nervous system disorders Nerve paralysis	0.09% 1/1057 • Number of events 1 • 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.
Cardiac disorders Pulmonary or other air embolism	0.28% 3/1057 • Number of events 3 • 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.
Nervous system disorders Seizures	0.38% 4/1057 • Number of events 4 • 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.
Nervous system disorders Status epilepticus	0.09% 1/1057 • Number of events 1 • 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.
Cardiac disorders Stroke or transient ischemic attack	0.19% 2/1057 • Number of events 2 • 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.
General disorders Other	0.95% 10/1057 • Number of events 10 • 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.

Other adverse events

Measure	Number of Participants With Adverse Events n=1057 participants at risk All eligible study subjects who underwent LITT with the NeuroBlate System.
Psychiatric disorders Anxiety	0.09% 1/1057 • Number of events 1 • 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.
Nervous system disorders Aphasia	0.66% 7/1057 • Number of events 7 • 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.
Nervous system disorders Ataxia or loss of body coordination	0.19% 2/1057 • Number of events 2 • 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.
Nervous system disorders Bleeding or increased risk of bleeding around the brain	2.8% 30/1057 • Number of events 30 • 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.
Nervous system disorders Blurry vision/visual disturbance	0.28% 3/1057 • Number of events 3 • 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.
Blood and lymphatic system disorders Cerebral edema/Edema	2.0% 21/1057 • Number of events 21 • 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.
Nervous system disorders Cerebral infarction	0.09% 1/1057 • Number of events 1 • 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.
Nervous system disorders Complete or incomplete hemiparesis	0.19% 2/1057 • Number of events 2 • 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.
Cardiac disorders Deep venous thrombosis	0.19% 2/1057 • Number of events 2 • 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.
Nervous system disorders Difficulty speaking	0.47% 5/1057 • Number of events 5 • 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.
Nervous system disorders Difficulty walking	0.28% 3/1057 • Number of events 3 • 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.
Nervous system disorders Headache	0.28% 3/1057 • Number of events 3 • 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.
Infections and infestations Infection or increased risk of infection	0.57% 6/1057 • Number of events 6 • 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.
Nervous system disorders Injury to brain tissue	0.19% 2/1057 • Number of events 2 • 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.
Musculoskeletal and connective tissue disorders Muscle weakness	1.4% 15/1057 • Number of events 16 • 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.
Gastrointestinal disorders Nausea/vomiting	0.09% 1/1057 • Number of events 1 • 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.
Nervous system disorders Nerve paralysis/paralysis	0.28% 3/1057 • Number of events 3 • 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.
Psychiatric disorders Personality or cognitive changes	0.28% 3/1057 • Number of events 3 • 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.
Infections and infestations Pneumonia	0.28% 3/1057 • Number of events 3 • 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.
Cardiac disorders Pulmonary or air embolism	0.66% 7/1057 • Number of events 7 • 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.
Nervous system disorders Seizure/increased seizures frequency, duration, or severity	1.8% 19/1057 • Number of events 22 • 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.
Nervous system disorders Status epilepticus	0.09% 1/1057 • Number of events 1 • 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.
Cardiac disorders Stroke or transient ischemic attack	0.19% 2/1057 • Number of events 2 • 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.
Nervous system disorders Tingling or numb sensations in the body	0.09% 1/1057 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Wound dehiscence	0.19% 2/1057 • Number of events 2 • 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.
General disorders Other	2.2% 23/1057 • Number of events 25 • 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.
Cardiac disorders Hypertension	0.09% 1/1057 • Number of events 1 • 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.

Additional Information

Christa Seligman

Monteris Medical

Phone: (952) 463-7747

Email: cseligman@monteris.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place