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

NCT07546253 | Not Yet Recruiting FDA Device

• 1 other identifier: N1-OneRF-Registry-01
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Refractory Epilepsy; Drug Resistant Epilepsy

Keywords

radiofrequency ablation; sEEG; epilepsy

Outcome Measures

Primary Outcomes (5)

• Evaluate seizure outcomes

  Percentage of seizure-free patients and responders (seizure reduction \>50%) at longitudinal time points

  baseline to up to one (1) year

• Evaluate changes in seizure frequency

  Change is seizure frequency at longitudinal time points

  baseline to up to one (1) year

• Evaluate changes in seizure severity

  Change is seizure severity at longitudinal time points

  baseline to up to one (1) year

• Evaluate antiseizure medication

  Changes in the antiseizure medication (ASM) dosage

  baseline to up to one (1) year

• Gather product deficiency and patient safety events

  Number and description of adverse events related to the device, user, RF ablation procedure, therapy, and others

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

Other Outcomes (8)

• Evaluate seizure related hospitalizations

  baseline to up to one (1) year

• Evaluate device use

  During the ablation procedure

• RF ablation parameters

  During RF ablation procedure

Study Arms (1)

Patients who have received or will receive an RF ablation procedure using the OneRF Ablation System

This registry collects both retrospective data from patients diagnosed with drug resistant epilepsy (DRE) who previously underwent a RF ablation procedure and prospective data from DRE patients who are considered for a RF ablation procedure using the OneRF Ablation System.

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

Interventions

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

For observational studies, participants are not assigned an intervention as part of the study.

Patients who have received or will receive an RF ablation procedure using the OneRF Ablation System

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with drug resistant epilepsy (DRE)

You may qualify if:

• 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.

You may not qualify if:

• \. Any condition that, in the judgement of the clinician, would make the participant inappropriate for registry participation

Sponsors & Collaborators

• NeuroOne Medical Technologies Corporation: lead

Related Publications (1)

• Zavala B, Kondylis E, Bulacio J, Chisholm J, Harasimchuk S, Rammo R, Bingaman W, Serletis D. Initial clinical experience with the first FDA-approved sEEG-guided radiofrequency ablation system featuring real-time temperature monitoring: A case series. Stereotact Funct Neurosurg. 2026 Mar 5:1-14. doi: 10.1159/000551390. Online ahead of print.

  PMID: 41785222 BACKGROUND

MeSH Terms

Conditions

Drug Resistant Epilepsy; Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 22, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share