Feasibility Study on LITT for Medical Refractory Epilepsy
Ključne riječi
Sažetak
Opis
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.
Datumi
| Posljednja provjera: | 07/31/2019 |
| Prvo podneseno: | 06/07/2016 |
| Predviđena prijava predata: | 06/27/2016 |
| Prvo objavljeno: | 06/30/2016 |
| Zadnje ažuriranje poslato: | 08/11/2019 |
| Posljednje ažuriranje objavljeno: | 08/13/2019 |
| Stvarni datum početka studija: | 04/20/2017 |
| Procijenjeni datum primarnog završetka: | 06/23/2019 |
| Predviđeni datum završetka studije: | 06/23/2019 |
Stanje ili bolest
Intervencija / liječenje
Device: NeuroBlate LITT Treatment
Faza
Grupe ruku
| Arm | Intervencija / liječenje |
|---|---|
| Other: NeuroBlate LITT Treatment This is a single arm study. All eligible study subjects will undergo LITT with the NeuroBlate System. | Device: NeuroBlate LITT Treatment Laser Interstitial Thermal Therapy |
Kriteriji prihvatljivosti
| Uzrast podoban za studiranje | 18 Years To 18 Years |
| Polovi podobni za studiranje | All |
| Prihvaća zdrave volontere | Da |
| Kriterijumi | 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 |
Ishod
Primarne mjere ishoda
1. Adverse events [2 Years]
2. Changes in neuropsychological functioning [1 Year]
Sekundarne mjere ishoda
1. Changes in seizure frequency [2 Years]
2. Surgical outcome classification [2 Years]
3. Changes in quality of life [2 Years]
