Medtronic Enterra II Neurostimulator
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Treating Self Reported Nausea and Vomiting using Enterra II during procedure
研究概览
简要总结
Humanitarian Device: Authorized by Federal (U.S.A.) Law for use in treatment of chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology.
详细描述
Description The Medtronic Enterra II Model 37800 Neurostimulator is a programmable device designed to deliver therapy through gastric electrical stimulation when connected to a lead system.
These components comprise the implantable portion of the Medtronic Enterra II system.
The operation of the neurostimulator is supported by a clinician programmer. The neurostimulator (Figure 1) operates on a sealed battery and electronic circuitry to provide controlled electrical pulse stimulation, through the implanted lead system.
A wide range of noninvasively programmable parameters and stimulation modes are available. The neurostimulator provides current parameter information, via telemetry, when used with the clinician programmer.
System Components
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology in patients aged 18 to 70 years.
排除标准
- •Organ transplant
- •Organic obstruction
- •Pseudo-obstruction
- •Prior gastric surgery
- •Scleroderma
- •Amyloidosis
- •History of seizures
- •Peritoneal or unstable dialysis
- •Chemical dependency
- •Pregnancy
- •Primary eating or swallowing disorders
- •Psychogenic vomiting
- •Implanted electronic medical devices
- •Age < 18 or > 70 years
结局指标
主要结局
Treating Self Reported Nausea and Vomiting using Enterra II during procedure
时间窗: Up to 30 days
Using Enterra II system to prevent self reported Nausea and vomiting during a procedure
次要结局
未报告次要终点