NCT03500887已完成不适用
A Pilot Study to Investigate Whether Intragastric Pressure During Food Intake Can be Measured Using an Intragastric Bag in Healthy Volunteers
Prof Dr Jan Tack2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2015年11月最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Intragastric pressure during food intake
研究概览
简要总结
In this pilot study the investigators test the hypothesis that gastric motility can be measured with an intragastric balloon.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •They are between 18-60 years old.
- •Male and female.
- •Patients must provide witnessed written informed consent prior to any study procedures being performed.
排除标准
- •They are older than 60 years old.
- •Have severely decreased kidney function.
- •Have severely decreased liver function.
- •Have severe heart disease, for example a history of irregular heartbeats, angina or heart attack.
- •Have severe lung disease.
- •Have severe psychiatric illness or neurological illness.
- •Have any gastrointestinal disease.
- •Have any dyspeptic symptoms.
- •Women that are pregnant or breastfeeding.
研究组 & 干预措施
1. Bag inflated so that intrabagpressure increases with 2 mmHg
Other
干预措施: intragastric bag (Device)
2. Bag inflated to ¾ volume of 1
Other
干预措施: intragastric bag (Device)
结局指标
主要结局
Intragastric pressure during food intake
时间窗: max 3 hours
The intragastric pressure determined with the manometer and the intragastric bag will be compare before, during and after nutrient drink infusion.
次要结局
未报告次要终点
研究者
Prof Dr Jan Tack
Prof.
Universitaire Ziekenhuizen KU Leuven
研究点 (2)
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