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

OneRF® Ablation System Post-Market Real-World Evidence Registry

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Drug Resistant Epilepsy; Refractory Epilepsy
• Intervention / Treatment: Other: Participants are not assigned an intervention as part of the study.

Detailed Description

Stereoelectroencephalography (SEEG) -guided radiofrequency (RF) ablation is a minimally invasive procedure that uses thin electrodes already placed in the brain for seizure diagnosis to deliver targeted heat to destroy brain tissue associated with epileptic seizures.

The OneRF Ablation System is a device cleared by the FDA in 2023 for this treatment. Since receiving FDA clearance, the OneRF Ablation System has been used in ablation procedures in patients with seizures at multiple hospitals. Early published clinical data show a meaningful decrease in seizure burden (1). One of the key features of the device is the ability to monitor and control temperature throughout the treatment. While the advantages of real-time temperature monitoring and control are increasingly being recognized, additional clinical information would be beneficial to understand the full impact of this technology on patient outcomes.

This study is a prospective and retrospective, multicenter, observational registry. The study will take place at up to 10 sites across the United States and is expected to enroll up to 100 participants, including both adults and children. The goal of the registry is to evaluate clinical outcomes and device performance of the OneRF Ablation System.

The study will include data collection from patients with drug resistant epilepsy who are undergoing sEEG evaluation for seizure diagnosis and treatment, and:

• Have already had an ablation procedure with the OneRF Ablation System, or
• Are being considered for treatment with the OneRF Ablation System as part of their clinical seizure evaluation.

Data will be collected from patients before and throughout routine follow-up visits for up to one year after the RF ablation procedure. The study will look at seizure control, quality of life, adverse events, how the procedure is performed, and factors that may predict which patients benefit most.

Taking part in this registry does not change a patient's medical care. The study only collects information from treatments and follow-up visits that are already part of routine practice care for seizure management.

• Study Type: Observational
• Enrollment (Estimated): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with drug resistant epilepsy (DRE)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.; For observational studies, participants are not assigned an intervention as part of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate seizure related hospitalizations	Changes in seizure related emergency department visits and hospitalizations	baseline to up to one (1) year
Evaluate device use	Questionnaire to assess clinician satisfaction with the device	During the ablation procedure
RF ablation parameters	Collect RF ablation parameters (temperature and time) used for treatment	During RF ablation procedure
RF ablation lesion characterization	Measurement of RF ablation lesion size from MRI	From enrollment through the completion of follow-up visits (approximately a one-year period)
Evaluate patient selection for RF ablation	Tabulate RF ablation parameters, lesion size and seizure outcomes for each participant	From ablation through the completion of follow-up visits (approximately a one-year period)
Evaluate health care resource utilization	Location of the procedure: operating room or epilepsy monitoring unit	During the ablation procedure
Evaluate health care resource utilization	Personnel required for procedure	During the ablation procedure
Evaluate health care resource utilization	Total cost of index procedure and follow-up cate, if permissible	From enrollment through the completion of follow-up visits (approximately a one-year period)

Collaborators and Investigators

• Sponsor: NeuroOne Medical Technologies Corporation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: April 6, 2026
• First Submitted That Met QC Criteria: April 16, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: radiofrequency ablation; epilepsy; sEEG
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Drug Resistant Epilepsy; Epilepsy
• Other Study ID Numbers: N1-OneRF-Registry-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No