Post-Market Real-World Evidence Registry for the NeuroOne OneRF® Ablation System for Epilepsy

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorNeuroOne Medical Technologies Corporation

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Participants are not assigned an intervention as part of the study.

Treatment groups

100 Participants
are divided into 1 treatment group

Locations

This trial has no locations