Collects real-world data on a device used to treat drug-resistant epilepsy
Gathers outcomes from patients with drug-resistant epilepsy who receive routine device-guided brain ablation.
Plain-language title generated from the registry record
Registry title: Post-Market Real-World Evidence Registry for the NeuroOne OneRF® Ablation System for Epilepsy
Key facts
- Where
- Livingston, Miami, and New Brunswick, United StatesSee the 3 sites
Where in United States
- Cooperman Barnabas Medical Center - 94 Old Short Hills RdLivingston, United StatesTaking people
- Nicklaus Children's HospitalMiami, United StatesTaking people
- Robert Wood Johnson University Hospital - 1 Robert Wood Johnson PlNew Brunswick, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- NeuroOne Medical Technologies Corporation
- Trial code
- NCT07546253
- Record updated
- 16 October 2026
- Original description
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.Read full original descriptionShow less
OneRF® Ablation System Post-Market Real-World Evidence Registry
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.
Inclusion: 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.
Exclusion: Any condition that, in the judgement of the clinician, would make the participant inappropriate for registry participation.