Indiana University Gastric Electrical Stimulation Registry
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- To develop a clinical registry in patients with GES therapy
研究概览
简要总结
The purpose of this study is to develop a clinical registry in patients with Gastric Electrical Stimulation (GES) therapy for gastroparesis to support future gastrointestinal therapies, medical procedures and diagnostics.
详细描述
This study will evaluate male and female patients at least 18 years of age, with gastroparesis, who will or have already undergone the implantation of a GES device
The study will be conducted at one center and approximately 1,000 subjects will be enrolled.
Subjects undergoing the GES implantation will be enrolled before the implantation and may have a baseline visit. The visit procedures will be conducted at the discretion of the investigator dependent on the clinical condition of the patient at that time.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergo implantation of a new GES device for medical refractory gastroparesis
排除标准
- •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
To develop a clinical registry in patients with GES therapy
时间窗: 3 years
The purpose of this study is to develop a clinical registry in patients with Gastric Electrical Stimulation (GES) therapy for gastroparesis to support future clinical and translational research. Gastroparesis is an illness caused by a delay of stomach emptying. Symptoms of gastroparesis include nausea, vomiting, weight loss, the feeling of being full right away when you start eating, and abdominal pain. The disease may also lead to malnutrition and weight loss. GES has shown promise in patients with gastroparesis. However, how the GES works is unclear, but the patients who undergo GES show improvement in their symptoms.
次要结局
未报告次要终点
研究者
John M. Wo
Director, GI Motility and Neurogastroenterology
Indiana University