Post-Market Real-World Evidence Registry for the NeuroOne OneRF® Ablation System for Epilepsy (NCT07546253) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Post-Market Real-World Evidence Registry for the NeuroOne OneRF® Ablation System for Epilepsy
100 participantsStarted 2026-07
Plain-language summary
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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate seizure outcomes
Timeframe: baseline to up to one (1) year
2
Evaluate changes in seizure frequency
Timeframe: baseline to up to one (1) year
3
Evaluate changes in seizure severity
Timeframe: baseline to up to one (1) year
4
Evaluate antiseizure medication
Timeframe: baseline to up to one (1) year
5
Gather product deficiency and patient safety events
Timeframe: From enrollment through the completion of follow-up visits (approximately a one-year period)