Multi-Channel Gastric Electrical Stimulation for the Treatment of Gastroparesis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Percentage of Slow Wave Entrainment
研究概览
简要总结
Investigate the safety and efficacy of multi-channel gastric electrical stimulation in the treatment of patients with severe diabetic gastroparesis refractory to standard therapy.
详细描述
Evaluation of severe symptom control of nausea, vomiting, postprandial fullness, early satiety, bloating and discomfort related to drug refractory gastroparesis present as a GI complication in diabetic patients. External gastric pacemaker system will be placed at the same time of implantation of Enterra (internal gastric stimulator-permanent device) to assess symptoms, quality of life improvement and investigate the changes in gastric emptying time in diabetic gastroparesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Severe nausea and vomiting for at least 6 months
- •Documented delayed gastric emptying
- •Failed extensive medical treatment
排除标准
- •Previous gastric surgery
- •Pregnancy or planned pregnancy
- •Primary eating or swallowing disorders
- •Scheduled or planned MRI testing
结局指标
主要结局
Percentage of Slow Wave Entrainment
时间窗: 12 Weeks
Participants were monitored for up to 3 months. Measure is the percent of normal slow waves (2-4 cpm) generated by MGP-1 device while it was ON or OFF
次要结局
- The Percent (Percentage) of Gastric Retention of a Solid Meal(12 Weeks)
- Changes in Quality of Life (QoL) Assessment (Physical (P) and Mental (M))(12 Weeks)
- Severity of Gastroparetic Symptoms(12 weeks)
- Changes in Hemoglobin A1c (HbA1c) Level(12 Weeks)
- Changes in Hospital Admissions(12 Weeks)