Randomized Study of Enterra Programming with Nocturnal Cycling in Gastroparetics
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Percent Change in Weekly Vomiting Frequency by GCSI-DD
研究概览
简要总结
The purpose of this research study is to evaluate if different Enterra® device programming methods active during sleeping hours can maintain gastroparesis-related symptom relief and quality of life measures.
Participants in this study with existing Enterra® devices will be randomly assigned to one of three programming methods that will be active during sleep. Participants will answer daily questions about their gastroparesis symptoms on an application with their phone/tablet. Participants will answer quality of life questionnaires about their gastroparesis symptoms at study visits.
Participants will be involved in the study for up to six months after treatment assignment.
Programming parameters in the study are within currently approved labeling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Percent Change in Weekly Vomiting Frequency by GCSI-DD
时间窗: 3 Months, 6 Months
Less than a 50% increase in GCSI-DD weekly vomiting frequency from baseline
Scoring Change in Nausea Severity by GCSI-DD
时间窗: 3 Months, 6 Months
Less than a 1-point increase in GCSI-DD nausea severity from baseline
次要结局
- Mean Change from Baseline in PAGI-QoL Scores(3 Months, 6 Months)
- Mean Change from Baseline in Quality of Sleep Scores(3 Months, 6 Months)
- Mean Change from Baseline in GCSI-DD Weekly Vomiting Frequency(3 Months, 6 Months)
- Mean Change from Baseline in GCSI-DD Total Symptom Score(3 Months, 6 Months)
- Mean Change from Baseline in GCSI-DD Nausea Severity(3 Months, 6 Months)