A Pilot Study to Assess the Feasibility of a Wireless Patch System (WPS) to Measure Gastrointestinal Motility and Gastric Emptying
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Subject willingness to wear a wireless patch system (WPS)
研究概览
简要总结
The purpose of this study is to evaluate the utility of a new device - an external wireless patch system (WPS) - to measure gastric motility and to compare this external wearable device with the most commonly used test to measure stomach emptying, the nuclear medicine gastric emptying scan (also called gastric scintigraphy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Referred to the nuclear medicine department for a scintigraphic gastric emptying scan.
排除标准
- •Have had prior gastric or esophageal surgery.
- •Have had surgery to the GI tract within the last 60 days (e.g., appendectomy, cholecystectomy).
- •Are on chronic opioids or other medications known to affect gastric emptying (e.g., GLP-1 agonists, high dose tricyclic agents).
- •Have been recently hospitalized for complications of diabetes or have a HgbA1c >
- •Have severe psychological distress preventing study participation.
- •Unable to read or understand the consent form.
研究组 & 干预措施
Wireless patch system (WPS)
Subjects scheduled for a gastric emptying scan will have a wireless patch system (WPS) placed.
干预措施: Scintigraphic gastric emptying scan (Diagnostic Test)
Wireless patch system (WPS)
Subjects scheduled for a gastric emptying scan will have a wireless patch system (WPS) placed.
干预措施: Wireless patch system (WPS) (Device)
结局指标
主要结局
Subject willingness to wear a wireless patch system (WPS)
时间窗: 7 days
Number of subjects to wear a wireless patch system (WPS) to evaluate upper gastrointestinal symptoms
次要结局
未报告次要终点