Multi-Center, Concurrent-Controlled, On-Label Study of the NeuRx Diaphragm Pacing System (DPS) in Participants With Amyotrophic Lateral Sclerosis (ALS)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Survival
研究概览
简要总结
The purpose of this research study is to collect more information about the use, safety, and effectiveness of the NeuRx DPS® in ALS patients.
详细描述
Characterize the safety and benefit of on-label Humanitarian Device Exemption (HDE) use of DPS in patients with ALS who initiated noninvasive ventilation (NIV).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open label
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 or older
- •Familial or sporadic ALS diagnosed as possible, laboratory-supported probable, probable, or definite according to the World Federation of Neurology El Escorial criteria
- •Bilateral phrenic nerve function clinically acceptable as demonstrated by bilateral diaphragm movement with fluoroscopic sniff test or with phrenic nerve conduction studies
- •Chronic hypoventilation was documented by at least one of the following:
- •MIP (respiratory muscle strength) less than 60 cmH2O, or
- •Forced Vital Capacity (FVC) less than 50% predicted, or
- •PaCO2 greater than or equal to 45 mmHg, or
- •Nocturnal SaO2 (arterial oxygen saturation) less than or equal to 88% for at least five continuous minutes
- •Initiation of non-invasive ventilation at or before time of enrollment
- •Suitable surgical candidate to receive diaphragm pacing stimulation
- •Negative pregnancy test in female participants of childbearing potential (treatment group)
- •Informed consent from patient or designated representative
排除标准
- •FVC less than 45% predicted within 10 days prior to surgery.
- •Participation in simultaneous therapeutic clinical trial which could affect the safety or benefit outcomes of this study.
研究组 & 干预措施
NeuRx DPS
Subjects who have initiated noninvasive ventilation (NIV) and receive the NeuRx diaphragm pacing system (DPS).
干预措施: NeuRx DPS (Device)
No DPS
Subjects who have initiated noninvasive ventilation (NIV) and do not receive the DPS device.
结局指标
主要结局
Survival
时间窗: 24 months
Compare the survival of patients who initiated noninvasive ventilation (NIV).and who receive DPS to controls without DPS: (1) concurrent controls; (2) historical controls (e.g., Lechtzin and PRO-ACT databases); and (3) virtual controls (Origent).
次要结局
- Frequency of device and procedure-related adverse events(24 months)
- Relationship between survival time and onset of weakness from ALS to treatment(24 months)
- Characterize change in overall and respiratory function(24 months)
- Relationship between survival time and ALS assessment scores(24 months)
- Characterize change in respiratory function(24 months)
- Frequency of respiratory adverse events(24 months)
- Relationship between survival time and ALS treatment interventions(24 months)
- Relationship between survival time and intraoperative strength of contraction(24 months)
- Types device and procedure-related adverse events(24 months)
- Types of respiratory serious adverse events(24 months)
- Relationship between survival time and clinical features of ALS(24 months)