NCT07546253 · NeuroOne Medical Technologies Corporation
Post-Market Real-World Evidence Registry for the NeuroOne OneRF® Ablation System for Epilepsy
What this study is about
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.
View original scientific 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.
Interventions
OTHER
Participants are not assigned an intervention as part of the study.
For observational studies, participants are not assigned an intervention as part of the study.
Primary outcome measures
Evaluate seizure outcomes
Time frame: baseline to up to one (1) year
Percentage of seizure-free patients and responders (seizure reduction \>50%) at longitudinal time points
Evaluate changes in seizure frequency
Time frame: baseline to up to one (1) year
Change is seizure frequency at longitudinal time points
Evaluate changes in seizure severity
Time frame: baseline to up to one (1) year
Change is seizure severity at longitudinal time points
Evaluate antiseizure medication
Time frame: baseline to up to one (1) year
Changes in the antiseizure medication (ASM) dosage
Gather product deficiency and patient safety events
Time frame: From enrollment through the completion of follow-up visits (approximately a one-year period)
Number and description of adverse events related to the device, user, RF ablation procedure, therapy, and others
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Exclusion criteria
- 1\. Any condition that, in the judgement of the clinician, would make the participant inappropriate for registry participation
Where
- Miami, Florida
- Livingston, New Jersey
- New Brunswick, New Jersey
Collaborators
Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 16, 2026 · Source of record for eligibility and locations