Drug Resistant EpilepsyNCT07546253
Post-Market Real-World Evidence Registry for the NeuroOne OneRF® Ablation System for Epilepsy
An observational study of Drug Resistant Epilepsy and Refractory Epilepsy, run by NeuroOne Medical Technologies Corporation at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Drug Resistant Epilepsy, Refractory Epilepsy
- What is being tested?
- Participants are not assigned an intervention as part of the study.
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 Sep 2026to Jul 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with drug resistant epilepsy (DRE)
Who may be able to join
- 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.
Who cannot join
- 1. Any condition that, in the judgement of the clinician, would make the participant inappropriate for registry participation
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Cooperman Barnabas Medical Center - 94 Old Short Hills Rd
Livingston, New Jersey, 07039
Robert E Gross, MD, PhD, 833-656-3876, rg1246@rutgers.edu
Robert E Gross, MD, PhD
- Recruiting
Nicklaus Children's Hospital
Miami, Florida, 33155
Robert Buckley, MD, 206-272-0879, robert.buckley@nicklaushealth.org
Robert Buckley, MD
- Recruiting
Robert Wood Johnson University Hospital - 1 Robert Wood Johnson Pl
New Brunswick, New Jersey, 08901
Robert E Gross, MD, PhD, 833-656-3876, rg1246@rwjms.rutgers.edu
Robert E Gross, MD, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Drug Resistant Epilepsy, Refractory Epilepsy
- Being tested
- Participants are not assigned an intervention as part of the study.
- Keywords
- radiofrequency ablation, sEEG, epilepsy
- Medical subject headings
- Drug Resistant Epilepsy, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Participants are not assigned an intervention as part of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate seizure outcomes
Percentage of seizure-free patients and responders (seizure reduction >50%) at longitudinal time points
Measured: baseline to up to one (1) year
Evaluate changes in seizure frequency
Change is seizure frequency at longitudinal time points
Measured: baseline to up to one (1) year
Evaluate changes in seizure severity
Change is seizure severity at longitudinal time points
Measured: baseline to up to one (1) year
Evaluate antiseizure medication
Changes in the antiseizure medication (ASM) dosage
Measured: 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
Measured: From enrollment through the completion of follow-up visits (approximately a one-year period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start18 Sep 2026
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Drug Resistant EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- NeuroOne Medical Technologies Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nicklaus Children's Hospital f/k/a Miami Children's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07546253
- Sponsor's protocol ID
- N1-OneRF-Registry-01
- Status last verified
- Oct 2026
- First submitted
- 6 Apr 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Freund BE, Vijayanarasimhan V, Safa A, Ekert J, Colella FE, Block C, Sabsevitz D, Perez-Vega C, Middlebrooks EH, Mirsattari SM, Byrne R, Tatum WO. Stereo-electroencephalography-guided radiofrequency thermocoagulation in patients with implanted neuromodulation devices: patient series. J Neurosurg Case Lessons. 2026 Aug 3;12(5):CASE26376. doi: 10.3171/CASE26376. Print 2026 Aug 3.
PubMed 42546343Zavala 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 5:1-8. doi: 10.1159/000551390. Online ahead of print.
PubMed 41785222