The Relationship Between Body Surface Gastric Mapping (BSGM) and Gastric Emptying Rate
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- Validation of body surface gastric mapping for delayed gastric emptying
研究概览
简要总结
Currently, a new generation of high-resolution electrogastrograms recording technology with 64-channel electrode array is being developed by Alimetry Limited. This BSGM provide a more complete understanding of the origin and propagation of human gastric slow-wave activity non-invasively, such as frequency, amplitude, velocity, and pattern, in high spatiotemporal detail. The system is also capable of providing a novel meal response metric, which might correlate with the gastric emptying time. The system includes an App for tracking patient-reported symptoms throughout the test.The aim of the present study is to assess and compare BSGM and breath-based gastric emptying parameters and to study the relation between BSGM and presence or severity of individual symptoms and clinical features.The investigators will perform a study in 100 subjects to record gastric bioelectrical activity by non-invasive multi-channel body-surface electrode arrays during gastric emptying breathing test.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged >18 years old;
- •Male or female patients;
- •Patients planned GEBT;
- •Negative PCR on nasopharyngeal swab 24 or 48 hours prior to the test;
- •Signed informed consent.
排除标准
- •Females who are pregnant or lactating.
- •History of skin allergies or a history of extreme sensitivity to cosmetics or lotions
- •Fragile skin vulnerable to skin tears.
- •Damaged epigastric skin (open wounds, rash, inflammation)
- •Patients unable to remain in a relaxed reclined position for the test duration
结局指标
主要结局
Validation of body surface gastric mapping for delayed gastric emptying
时间窗: 30 minutes before the meal and 4 hours after having meal.
The correlation of electrogastrography abnormality (in percentage) and delayed gastric emptying (t 1/2, minutes) will be determined employing a regression method.
次要结局
- To assess correlation between electrogastrography abnormality and upper gastrointestinal symptoms.(30 minutes before the meal and 4 hours after having meal.)