NCT02164591终止不适用
Escalating Temporary Gastric Electrical Stimulation for Severe Gastroparesis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Improvement in the symptoms of gastroparesis by t-GES in patients with severe gastroparesis.
研究概览
简要总结
The purpose of this study is to determine the physiologic effects of temporary gastric electrical stimulation in subjects with severe gastroparesis.
详细描述
This study will look to determine the clinical benefit placing temporary gastric electrical stimulation, the ability to predict the clinical response to surgical implantation of GES, and the feasibility and patient tolerability of endoscopic placement of temporary Gastric Electrical Stimulator (t-GES),
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 3 months of gastroparesis-related symptoms, such as nausea, emesis, and/or retching
- •Solid phase 4-hr gastric scintigraphy is consistent with gastroparesis within 3 months of study enrollment*
- •retention at 2 hr: >60% or
- •retention at 4 hr: >10% *Based on International consensus on gastric scintigraphy
排除标准
- •Gastric outlet, small bowel, or colon obstruction.
- •Small bowel malrotation
- •Inflammatory bowel disease
- •Contraindication for surgical implantation of GES
- •Presence of illness that may require MRI during the study; such as pituitary tumor, herniated disc, spinal stenosis, multiple sclerosis, etc.
- •Significant comorbidity due to sever cardiovascular, renal, pulmonary, or liver disease.
- •Significant coagulopathy
- •Non-ambulatory patients: bed-ridden, nursing home resident, etc.
- •Pregnancy
- •Unable to give own informed consent
- •Prisoners
结局指标
主要结局
Improvement in the symptoms of gastroparesis by t-GES in patients with severe gastroparesis.
时间窗: 1 month
Review the symptoms before and after the t-GES placements and follow for any improvement
次要结局
- Clinical response to t-GES placement as measured by questionnaires(1 year)
- determine the feasibility and patient tolerability of endoscopic placement of t-GES(1 year)
- Develop a prospective registry in patients undergoing escalating t-GES(1 year)
研究者
研究点 (1)
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