OneRF® Ablation System Post-Market Real-World Evidence Registry
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- NeuroOne Medical Technologies Corporation
- 入组人数
- 100
- 主要终点
- Evaluate seizure outcomes
概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •1\. Any condition that, in the judgement of the clinician, would make the participant inappropriate for registry participation
研究组 & 干预措施
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.
干预措施: Participants are not assigned an intervention as part of the study. (Other)
结局指标
主要结局
Evaluate seizure outcomes
时间窗: baseline to up to one (1) year
Percentage of seizure-free patients and responders (seizure reduction \>50%) at longitudinal time points
Evaluate changes in seizure frequency
时间窗: baseline to up to one (1) year
Change is seizure frequency at longitudinal time points
Evaluate changes in seizure severity
时间窗: baseline to up to one (1) year
Change is seizure severity at longitudinal time points
Evaluate antiseizure medication
时间窗: baseline to up to one (1) year
Changes in the antiseizure medication (ASM) dosage
Gather product deficiency and patient safety events
时间窗: From enrollment through the completion of follow-up visits (approximately a one-year period)
Number and description of adverse events related to the device, user, RF ablation procedure, therapy, and others
次要结局
未报告次要终点