Gastrointestinal Transit Times and Motility in Healthy Volunteers Obtained by Motilis-3D-transit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Total gastrointestinal transit time in healthy subjects.
研究概览
简要总结
The purpose of this study is to describe gastrointestinal motility and transit times in healthy subjects by using Motilis 3D-Transit and to compare the total gastrointestinal transit time (GITT) to GITT obtained using radioopaque markers.
The investigators end points are to measure the transit times through different segments of the gastrointestinal canal,e.g. gastric emptying, small intestine, total GITT.
The study is descriptive and is designed to test and evaluate the usefulness of the Motilis 3D-Transit system. The investigators hypothesize, that with the system transit times through different segments of the gastrointestinal canal can be measured.
The design is made for evaluating the transit times, the inter-subject reproducibility and comparison with gold standard for colonic transit time measurement.
The investigators have chosen to include 20 healthy volunteers.The study is descriptive and therefore power calculation is not needed.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Volunteer
- •Signed informed consent obtained
- •Fasted since midnight
排除标准
- •Subject has known GI related symptoms complaints or GI diseases, including swallowing disorders
- •Subject has cancer or other life threatening diseases or conditions
- •Subject is pregnant
- •Subject has undergone abdominal surgery
- •Subject has abdominal diameter >140cm?
- •Drug abuse or alcoholism
- •Subject's bowel movements are irregular
- •Subject has known cardiovascular or pulmonary diseases
- •Participation in any clinical study within the last 30 days
- •Subject has cardiac pacemaker or infusion pump or any other implanted or portable electro-mechanical medical device.
- •Subject takes any medication affecting GI motility
- •Subject having MRI within the next four weeks
结局指标
主要结局
Total gastrointestinal transit time in healthy subjects.
时间窗: Three days from baseline visit
次要结局
- Segmental transit times in healthy subjects(Three days from Baseline visit)