Gastric Electrical Stimulation for Treating Abdominal Pain in Patients With Gastroparesis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Abdominal Pain
研究概览
简要总结
To conduct a pilot study to evaluate the effects of new GES programming settings on abdominal pain in patients with gastroparesis and existing GES devices, whose abdominal pain has so far been refractory to drugs and/or devices.
详细描述
Eligible patients will undergo detailed pain assessments as well as non-invasive physiologic assessment. Patients existing GES devices will be reprogrammed to new setting for 4 week and their GI symptoms including pain will be evaluated by a daily diary. At the end of 4 weeks detailed pain assessments and noninvasive physiologic assessments will be repeated.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Should be able to give informed consent for the study
- •Has Enterra GES device in place for at least 2 months
- •Continue to have moderate to severe abdominal pain on at least one pain questionnaire or >5 score (on a scale of 0-10 for pain) on the VAS questionnaire for at least 2 months.
- •Abdominal pain should be either persistent; for example, daily for at least >1 hour, be chronic for >2 months, and refractory to original Enterra GES settings
排除标准
- •Unable to provide informed consent
- •Pregnancy
- •Any other active health problems that would render patient unable to complete the study
结局指标
主要结局
Abdominal Pain
时间窗: 4 weeks
Abdominal Pain by Brief Pain Inventory. The values are 0-10, with 10 being worse outcome.
次要结局
未报告次要终点
研究者
Thomas Abell
Professor
University of Louisville