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.
Patients diagnosed with drug resistant epilepsy (DRE)
Patients who have received or will receive EVO® sEEG-RF implants
Patients who have undergone or may undergo an RF ablation procedure using the OneRF Ablation System.
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.
None
Patients diagnosed with drug resistant epilepsy (DRE)
Cohort
Other
Participants are not assigned an intervention as part of the study.
Other interventionFor observational studies, participants are not assigned an intervention as part of the study.
Evaluate seizure outcomes
Percentage of seizure-free patients and responders (seizure reduction \>50%) at longitudinal time points
Evaluate changes in seizure frequency
Change is seizure frequency at longitudinal time points
Evaluate changes in seizure severity
Change is seizure severity at longitudinal time points
Evaluate antiseizure medication
Changes in the antiseizure medication (ASM) dosage
Evaluate seizure related hospitalizations
Changes in seizure related emergency department visits and hospitalizations
Evaluate device use
Questionnaire to assess clinician satisfaction with the device
RF ablation parameters
Collect RF ablation parameters (temperature and time) used for treatment
RF ablation lesion characterization
Measurement of RF ablation lesion size from MRI
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This trial is not recruiting at the moment. You can still explore other options:
