Feasibility Study on LITT for Medical Refractory Epilepsy
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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. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02820740 |
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Recruitment Status :
Active, not recruiting
First Posted : July 1, 2016
Last Update Posted : March 22, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Epilepsy | Device: NeuroBlate System | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 30 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Feasibility Study on Laser Interstitial Thermal Therapy Ablation for the Treatment of Medical Refractory Epilepsy (FLARE) |
| Actual Study Start Date : | April 21, 2017 |
| Estimated Primary Completion Date : | December 2019 |
| Estimated Study Completion Date : | December 2019 |
| Arm | Intervention/treatment |
|---|---|
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NeuroBlate LITT Treatment
This is a single arm study. All eligible study subjects will undergo LITT with the NeuroBlate System.
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Device: NeuroBlate System
Laser Interstitial Thermal Therapy |
- Adverse events [ Time Frame: 2 Years ]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.
- Changes in neuropsychological functioning [ Time Frame: 1 Year ]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.
- Changes in seizure frequency [ Time Frame: 2 Years ]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.
- Surgical outcome classification [ Time Frame: 2 Years ]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.
- Changes in quality of life [ Time Frame: 2 Years ]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 questionnaire.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Relevant Inclusion Criteria are listed below
- Diagnosis of unilateral medial temporal lobe epilepsy (MTLE) confirmed clinically and with either (1) ictal scalp recording and MRI evidence of mesial temporal sclerosis or (2) intracranial ictal onset consistent with hippocampal origin
- Averages 1 or more complex partial seizures or secondary generalized seizures compatible with MTLE per month
- On stable antiepileptic medications
- Meets the criteria for a medial temporal lobe resection and is a candidate for LITT
- 18 years or older at the time of consent
Relevant Exclusion Criteria are listed below
- Previous diagnosis of psychogenic/non-epileptic seizures
- Previous diagnosis of primary generalized seizures
- IQ less than 70
- Subject has a MRI-incompatible implanted electronic device or any metallic prosthesis or implant for which brain MRI is contraindicated
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): NCT02820740
| United States, Arizona | |
| St. Joseph's Hospital and Medical Center | |
| Phoenix, Arizona, United States, 85013 | |
| United States, Connecticut | |
| Yale University School of Medicine | |
| New Haven, Connecticut, United States, 06520 | |
| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160 | |
| United States, New York | |
| Mount Sinai West | |
| New York, New York, United States, 10019 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| Principal Investigator: | Dennis Spencer, MD | Yale University |
| Responsible Party: | Monteris Medical |
| ClinicalTrials.gov Identifier: | NCT02820740 History of Changes |
| Other Study ID Numbers: |
FLARE |
| First Posted: | July 1, 2016 Key Record Dates |
| Last Update Posted: | March 22, 2018 |
| Last Verified: | March 2018 |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | Yes | |
| Device Product Not Approved or Cleared by U.S. FDA: | No | |
| Pediatric Postmarket Surveillance of a Device Product: | No | |
Keywords provided by Monteris Medical:
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Epilepsy Medial Temporal Lobe Epilepsy Seizure |
NeuroBlate LITT Quality of Life |
Additional relevant MeSH terms:
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Epilepsy Drug Resistant Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases |