NCT07546253 Post-Market Real-World Evidence Registry for the NeuroOne OneRF® Ablation System for Epilepsy
| NCT ID | NCT07546253 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NeuroOne Medical Technologies Corporation |
| Condition | Drug Resistant Epilepsy |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-09-18 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2026-09-18 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07546253 clinical trial?
This trial is open to participants of all sexes, studying Drug Resistant Epilepsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07546253 currently recruiting?
Yes, NCT07546253 is actively recruiting participants. Contact the research team at aurak@nmtc1.com for enrollment information.
Where is the NCT07546253 trial being conducted?
This trial is being conducted at Miami, United States, Livingston, United States, New Brunswick, United States.
Who is sponsoring the NCT07546253 clinical trial?
NCT07546253 is sponsored by NeuroOne Medical Technologies Corporation. The trial plans to enroll 100 participants.
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