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

SexALL

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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.

What they're measuring

Evaluate seizure outcomes

Timeframe: baseline to up to one (1) year

Evaluate changes in seizure frequency

Timeframe: baseline to up to one (1) year

Evaluate changes in seizure severity

Timeframe: baseline to up to one (1) year

Evaluate antiseizure medication

Timeframe: baseline to up to one (1) year

Gather product deficiency and patient safety events

Timeframe: From enrollment through the completion of follow-up visits (approximately a one-year period)

Trial details

NCT IDNCT07546253

SponsorNeuroOne Medical Technologies Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2028-07

View on ClinicalTrials.gov More Drug Resistant Epilepsy trials