Real-world use of the OneRF Ablation System for epilepsy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter registry that prospectively and retrospectively collects data from up to 100 participants at up to 10 US sites. It focuses on patients undergoing SEEG-guided RF ablation with the OneRF device, documenting seizure outcomes and device performance in routine care. Data include safety, efficacy, and real-time temperature control during procedures, with both adult and pediatric participants. No specific intervention is assigned by the study; it observes standard-of-care practices. Eligibility includes confirmed drug-resistant epilepsy and receipt or planned use of EVO SEEG-RF implants with the OneRF system.

Why it matters

Who can join: the full rules

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

Where it's running

• Nicklaus Children's Hospital
  Miami, Florida, United States Recruiting
• Cooperman Barnabas Medical Center - 94 Old Short Hills Rd
  Livingston, New Jersey, United States Recruiting
• Robert Wood Johnson University Hospital - 1 Robert Wood Johnson Pl
  New Brunswick, New Jersey, United States Recruiting

Study contacts

• Study coordinator: Aura Kullmann, PhD
• Email: aurak@nmtc1.com
• Phone: 4123393027

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.