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Post-Market Real-World Evidence Registry for the NeuroOne OneRF® Ablation System for Epilepsy
RecruitingObservational study
OneRF® Ablation System Post-Market Real-World Evidence Registry
Who can join
All ages · All sexes
Full eligibility criteria
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 the judgement of the clinician, would make the participant inappropriate for registry participation
About the study
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.
What is being tested
- Participants are not assigned an intervention as part of the study. (other)
Sponsor: NeuroOne Medical Technologies Corporation · Participants: 100 · Started: Sep 18, 2026
Contact the study team
- Aura Kullmann, PhD · Phone: 4123393027
Official record on ClinicalTrials.gov — NCT07546253
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.