New registry tracks brain ablation device for Tough-to-Treat epilepsy
NCT ID NCT07546253
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study will collect real-world data from 100 people with drug-resistant epilepsy who receive or are considered for a procedure using the OneRF Ablation System. The system uses radiofrequency energy to target and destroy small areas of brain tissue causing seizures. Researchers will track seizure control, medication changes, and device safety over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this registry could provide real-world evidence on how well the OneRF Ablation System controls seizures in people with drug-resistant epilepsy.
- What could go wrong
- This is an observational registry, not a controlled trial, so results may be influenced by patient selection or other treatments. It is not designed to prove the device works better than alternatives.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients diagnosed with drug resistant epilepsy (DRE)
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Ketamine, long used as an anesthetic, tested as a seizure treatment
- Sound waves aimed at the brain may quiet temporal lobe seizures
- Can a new implant tame seizures when drugs fail?
- Can a High-Fat diet and therapy tame seizures in rare childhood epilepsy?
- Zapping the brain without surgery: a new hope for Tough-to-Treat epilepsy
- Nerve block may cut opioid needs after epilepsy device surgery