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Multicenter, open-label, prospective designed study to characterize the performance of brain laser interstitial thermal therapy (LITT) ablation using the Monteris NeuroBlate System for the treatment of drug-refractory medial temporal lobe epilepsy in subjects who are candidates for LITT surgery.
Monteris is sponsoring this multicenter, open-label, prospective feasibility study to characterize the performance of laser interstitial thermal therapy (LITT) using the Monteris NeuroBlate System for the treatment of drug-refractory medial temporal lobe epilepsy in subjects who are candidates for LITT surgery.
The NeuroBlate System uses precise, high-intensity laser light to initiate necrosis of abnormal brain tissue through thermal ablation while limiting injury to healthy tissue. Unlike traditional brain surgery, LITT does not require a large opening in the skull.
Subjects who meet the study eligibility criteria and sign the informed consent form will undergo the LITT procedure. Subjects, or their caregivers, are required to keep a seizure diary throughout the study, beginning after surgery. The study will monitor and record subjects' seizure frequency, antiepileptic medications, and physical and emotional health.
Subjects treated with NeuroBlate will have 2 years of follow-up. Throughout study participation, the study investigator will continuously monitor and document both effectiveness and safety data at study appointments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NeuroBlate LITT Treatment | Other | This is a single arm study. All eligible study subjects will undergo LITT with the NeuroBlate System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeuroBlate System | Device | Laser Interstitial Thermal Therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Characterize adverse events experienced in medial temporal lobe epilepsy subjects undergoing LITT using the NeuroBlate System. Adverse events will be collected based on subject reports and subject examination/testing. | 2 Years |
| Changes in Neuropsychological Functioning | Characterize changes to neuropsychological functioning experienced in medial temporal lobe epilepsy subjects undergoing LITT using the NeuroBlate System. Descriptive statistics (via neuropsychological assessment tools) will be reported for the measured score at baseline and each follow-up visit. | 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Seizure Frequency | Characterize changes in seizure frequency experienced in medial temporal lobe epilepsy subjects undergoing LITT using the NeuroBlate System by utilizing patient diary to evaluate seizure occurrences. | 2 Years |
| Surgical Outcome Classification |
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Relevant Inclusion Criteria are listed below
Relevant Exclusion Criteria are listed below
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| Name | Affiliation | Role |
|---|---|---|
| Dennis Spencer, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Hospital and Medical Center | Phoenix | Arizona | 85013 | United States | ||
| Yale University School of Medicine |
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| ID | Title | Description |
|---|---|---|
| FG000 | NeuroBlate LITT Treatment | All eligible study subjects who underwent LITT with the NeuroBlate System. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NeuroBlate LITT Treatment | All eligible study subjects who underwent LITT with the NeuroBlate System. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median |
| 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 | Number of Participants With Adverse Events | Characterize adverse events experienced in medial temporal lobe epilepsy subjects undergoing LITT using the NeuroBlate System. Adverse events will be collected based on subject reports and subject examination/testing. | The per-protocol analysis was not completed because the study was terminated early and the data collected was insufficient for the analysis despite two subjects completing the study at 24 months. | Posted | Count of Participants | Participants | 2 Years |
|
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Adverse events were collected from the time of patient consent (prior to the surgical procedure) to study withdraw/completion, up to 24 months.
A planned study sample size of thirty (30) enrolled and treated subjects would allow events that have a 5% probability per-subject an approximately 80% chance of being observed in at least one subject in the study. Due to the inability to enroll in the FLARE study and early termination, there are insufficient data regarding adverse event rates. The two (2) reported events are captured for the patients who underwent LITT.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NeuroBlate LITT Treatment | All eligible study subjects who underwent LITT with the NeuroBlate System. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tinnitus | Nervous system disorders | Non-systematic Assessment |
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The per-protocol analysis was not completed because the study was terminated early and data was insufficient for analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Program Manager | Monteris Medical | 763-401-1727 | medicalaffairs@monteris.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 6, 2017 | May 4, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 11, 2017 | Aug 22, 2023 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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Characterize the Engel and ILAE surgical outcome classification in medial temporal lobe epilepsy subjects undergoing LITT using the NeuroBlate System. Classifications will be determined by the Investigator. Engel Scale Class I: Free of disabling seizures Class II: Rare disabling seizures Class III: Worthwhile improvement Class IV: No worthwhile improvement ILAE Outcome Scale Class 1: Completely seizure free; no auras Class 2: Only auras; no other seizures Class 3: 1 to 3 seizure days per year; ± auras Class 4: 4 seizure days per year to 50% reduction of baseline seizure days; ± auras Class 5: Less than 50% reduction of baseline seizure days; ± auras Class 6: More than 100% increase of baseline seizure days; ± auras |
| 2 Years |
| Changes in Quality of Life | Characterize the changes in quality of life in subjects with medical temporal lobe epilepsy undergoing LITT using the NeuroBlate System. Quality of life will be measured using the QOLIE-31 (Quality of Life in Epilepsy) questionnaire. Score scale 0-100 with 100 indicating a higher reported quality of life across seven different categories (seizure worry, overall quality of life, social functioning, emotional wellbeing, medication effects, energy/fatigue, and cognitive functioning). | 2 Years |
| New Haven |
| Connecticut |
| 06520 |
| United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Mount Sinai West | New York | New York | 10019 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Primary | Changes in Neuropsychological Functioning | Characterize changes to neuropsychological functioning experienced in medial temporal lobe epilepsy subjects undergoing LITT using the NeuroBlate System. Descriptive statistics (via neuropsychological assessment tools) will be reported for the measured score at baseline and each follow-up visit. | The per-protocol analysis was not completed because the study was terminated early and the data collected was insufficient for the analysis. | Posted | Mean | Full Range | Time in seconds | 1 Year |
|
|
|
| Secondary | Changes in Seizure Frequency | Characterize changes in seizure frequency experienced in medial temporal lobe epilepsy subjects undergoing LITT using the NeuroBlate System by utilizing patient diary to evaluate seizure occurrences. | The per-protocol analysis was not completed because the study was terminated early and the data collected was insufficient for the analysis. | Posted | Median | Full Range | Number of seizures/month | 2 Years |
|
|
|
| Secondary | Surgical Outcome Classification | Characterize the Engel and ILAE surgical outcome classification in medial temporal lobe epilepsy subjects undergoing LITT using the NeuroBlate System. Classifications will be determined by the Investigator. Engel Scale Class I: Free of disabling seizures Class II: Rare disabling seizures Class III: Worthwhile improvement Class IV: No worthwhile improvement ILAE Outcome Scale Class 1: Completely seizure free; no auras Class 2: Only auras; no other seizures Class 3: 1 to 3 seizure days per year; ± auras Class 4: 4 seizure days per year to 50% reduction of baseline seizure days; ± auras Class 5: Less than 50% reduction of baseline seizure days; ± auras Class 6: More than 100% increase of baseline seizure days; ± auras | The per-protocol analysis was not completed because the study was terminated early and the data collected was insufficient for the analysis. | Posted | Number | participants | 2 Years |
|
|
|
| Secondary | Changes in Quality of Life | Characterize the changes in quality of life in subjects with medical temporal lobe epilepsy undergoing LITT using the NeuroBlate System. Quality of life will be measured using the QOLIE-31 (Quality of Life in Epilepsy) questionnaire. Score scale 0-100 with 100 indicating a higher reported quality of life across seven different categories (seizure worry, overall quality of life, social functioning, emotional wellbeing, medication effects, energy/fatigue, and cognitive functioning). | The per-protocol analysis was not completed because the study was terminated early and the data collected was insufficient for the analysis. | Posted | Median | Full Range | QOLIE Score (0-100) | 2 Years |
|
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| 0 |
| 2 |
| 2 |
| 2 |
| 0 |
| 2 |
| Infection | Gastrointestinal disorders | Non-systematic Assessment | Appendix removal |
|
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
| 1 Year Trails Making B |
|
| Title | Measurements |
|---|---|
|
| ILAE Class 1 at 2 years |
|