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Recruiting
NCT07546253
Post-Market Real-World Evidence Registry for the NeuroOne OneRF® Ablation System for Epilepsy
Conditions: Drug Resistant Epilepsy, Refractory Epilepsy
Sex: All
Healthy volunteers: No
Enrollment: 100
Sponsor: NeuroOne Medical Technologies Corporation
Location: Nicklaus Children's Hospital Miami Florida
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07546253). StuddyBuddy aggregates publicly available trial information.