Recruiting

OneRF Ablation System

Sponsor:

NeuroOne Medical Technologies Corporation

Code:

NCT07546253

Conditions

Drug Resistant Epilepsy

Refractory Epilepsy

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Drug Resistant Epilepsy

Refractory Epilepsy

Study ID

NCT07546253

Start date

Sep 18, 2026

Status verified date

Oct, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Evaluate seizure outcomes [ Time Frame: baseline to up to one (1) year ]
  • Evaluate changes in seizure frequency [ Time Frame: baseline to up to one (1) year ]
  • Evaluate changes in seizure severity [ Time Frame: baseline to up to one (1) year ]
  • Evaluate antiseizure medication [ Time Frame: baseline to up to one (1) year ]
  • Gather product deficiency and patient safety events [ Time Frame: From enrollment through the completion of follow-up visits (approximately a one-year period) ]

Central Contacts and Locations

Central contacts

Aura Kullmann, PhD

4123393027aurak@nmtc1.com

Locations

Nicklaus Children's Hospital

Recruiting

Miami, Florida, United States, 33155

Contacts

Robert Buckley, MD

206-272-0879robert.buckley@nicklaushealth.org

Principal Investigator:

Robert Buckley, MD

Cooperman Barnabas Medical Center - 94 Old Short Hills Rd

Recruiting

Livingston, New Jersey, United States, 07039

Contacts

Robert E Gross, MD, PhD

833-656-3876rg1246@rutgers.edu

Principal Investigator:

Robert E Gross, MD, PhD

Robert Wood Johnson University Hospital - 1 Robert Wood Johnson Pl

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Robert E Gross, MD, PhD

833-656-3876rg1246@rwjms.rutgers.edu

Principal Investigator:

Robert E Gross, MD, PhD

More Information

Sponsor

NeuroOne Medical Technologies Corporation

Last update posted

Oct 16, 2026

Last verified

Oct, 2026

Keywords

  • radiofrequency ablation
  • sEEG
  • epilepsy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-17. This information was provided to ClinicalTrials.gov by NeuroOne Medical Technologies Corporation on 2026-10-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.