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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| 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) |
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| 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 |
Inclusion Criteria:
Exclusion Criteria:
1. Any condition that, in the judgement of the clinician, would make the participant inappropriate for registry participation
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Patients diagnosed with drug resistant epilepsy (DRE)
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41785222 | Background | 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 5:1-8. doi: 10.1159/000551390. Online ahead of print. |
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| ID | Term |
|---|---|
| D000069279 | Drug Resistant Epilepsy |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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) |