RNS® System Post-Approval Study in Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- NeuroPace
- 入组人数
- 375
- 试验地点
- 35
- 主要终点
- Neurosurgeon experience
研究概览
简要总结
The purpose of the study is to follow patients with partial onset seizures prospectively over 5 years in the real-world environment to gather data on the long-term safety and effectiveness of the RNS System at qualified CECs by qualified neurologists, epileptologists, and neurosurgeons trained on the RNS System.
详细描述
NeuroPace, Inc. is sponsoring a post-approval study (PAS) of the RNS System device. The RNS System is the first FDA-approved closed loop responsive neurostimulator designed to reduce the frequency of seizures in individuals with partial onset seizures.
The RNS System Epilepsy PAS is a 5 year, non-randomized, open-label, multi-center prospective observational study. Data regarding safety and efficacy are collected at enrollment and periodically throughout the 5-year study.
The study is designed to assess the long-term safety and effectiveness of the RNS System as an adjunctive therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures who have undergone diagnostic testing that localized no more than 2 epileptogenic foci, are refractory to two or more antiepileptic medications, and currently have frequent and disabling seizures (motor partial seizures, complex partial seizures and/or secondarily generalized seizures).
Data from the RNS System Epilepsy PAS will be used to calculate long-term SAE rates, median percent change in seizure frequency (from pre-implant retrospective data), as well as other safety and effectiveness endpoints.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical decision to treat the patient with the RNS System in accordance with its approved indication for use has been made prior to enrollment in the study. For approved indication for use and contraindications, refer to current physician labeling and instructions for use (manuals) for the RNS System available at the NeuroPace website (www.neuropace.com).
- •This post-approval study also has the following additional study related inclusion criteria:
- •Subject or legal guardian is able to provide appropriate consent to participate
- •Subject is able to maintain a seizure diary alone or with the assistance of a competent individual
- •Subject is able to attend clinic appointments in accordance with the study schedule
排除标准
- •Per clinician assessment, treatment with the RNS System is contraindicated based on current RNS System labeling. For approved indication for use and contraindications, refer to current physician labeling and instructions for use (manuals) for the RNS System available at the NeuroPace website (www.neuropace.com).
- •This post-approval study has the following additional study related exclusion criteria:
- •Subject is participating in a therapeutic investigational drug or device study
- •Subject was treated with a VNS within the last three months (90 days)
- •Subject is pregnant
结局指标
主要结局
Neurosurgeon experience
时间窗: Implant through 41 days post-implant
Demonstrate there is no difference in safety in 6-week perioperative period based on the experience of NeuroPace qualified and trained implanting physicians.
SAE rate
时间窗: Implant through 5 years post-implant
Calculate annual SAE rates over time in the entire subject population as well as within subpopulations.
Autopsy
Present data from autopsies obtained from any patient implanted with neurostimulator/leads.
Physician experience
时间窗: Implant through 1 year post-implant
Demonstrate there is no difference in safety 1 year post-implant based on experience of NeuroPace qualified and trained treating physicians and Comprehensive Epilepsy Centers.
Product use - surgical procedures
Present the incidence and number of AEs related to surgical procedures associated with implant, explant, reimplantation, and revision of the neurostimulator and lead(s).
Median percentage reduction in disabling seizure
时间窗: Pre-implant (retrospective data) compared to 30 to 36 months post-implant
Demonstrate that the median percentage reduction in disabling seizures over time in the entire subject population is comparable to the median percentage reduction in disabling seizures over time in the LTT study. Characterize the median percentage reduction in disabling seizures over time within subpopulations.
Neurostimulator programming
时间窗: Through 5 years post-implant
Demonstrate that stimulation programming classes have similar effects on the overall seizure frequency.
次要结局
- Neurostimulator programming(Implant through 5 years post-implant)
- Seizure worsening(6 months post-implant through 36 months post-implant)