Post-Market Real-World Evidence Registry For The NeuroOne OneRF® Ablation System For Epilepsy

Overview

About this 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 06/15/2026. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Brin Freund, M.D.

Contact us for the latest status

Contact information:

Brin Freund

9049536869

freund.brin@mayo.edu

More information

Publications

  • Stereoelectroencephalography-guided radiofrequency ablation (sEEG-RFA) has been used to create stereotactic lesions in epileptic networks. The method has been applied as a diagnostic (and at times, palliative) intervention, primarily in European epilepsy programs. To date, the technique has not been widely popularized in the USA given the lack of FDA-approved technology permitting safe usage of in situ sEEG electrodes for this purpose. Recently, the FDA approved a new hollow sEEG electrode and OneRF generator (NeuroOne) featuring real-time thermal monitoring. Read More on PubMed