NeuroOne Medical Technologies Corporation
This is a multi-site registry study that aims to collect real-world clinical outcomes and device performance of the OneRF Ablation System. The study focuses on patients with refractory epilepsy who undergo, or are being considered for, sEEG-guided RF ablation using the OneRF Ablation System, as part of routine seizure diagnosis and treatment.
Stereoelectroencephalography (SEEG) -guided radiofrequency (RF) ablation is a minimally invasive procedure that uses thin electrodes already placed in the brain for seizure diagnosis to deliver targeted heat to destroy brain tissue associated with epileptic seizures. The OneRF Ablation System is a device cleared by the FDA in 2023 for this treatment. Since receiving FDA clearance, the OneRF Ablation System has been used in ablation procedures in patients with seizures at multiple hospitals. Early published clinical data show a meaningful decrease in seizure burden (1). One of the key features…
Inclusion Criteria: 1. Patients diagnosed with drug resistant epilepsy (DRE) 2. Patients who have received or will receive EVO® sEEG-RF implants 3. Patients who have undergone or may undergo an RF ablation procedure using the OneRF Ablation System. 4. Patient, or legal guardian, understands study procedures and voluntarily signs informed consent in accordance with institutional policies. In the event that the patient is under the age of 18, the patient may also be required (per IRB) to sign an assent affirming their agreement to participate. Exclusion Criteria: 1\. Any condition that, in th…
For observational studies, participants are not assigned an intervention as part of the study.
Arctuva estimate
Verify or correct the compensation shown for this listing.